THESIS PROTOCOL FOR THE AWARD OF

DIPLOMATE OF NATIONAL BOARD

OPHTHALMOLOGY

COMPARATIVE EVALUATION OF CORNEAL

ENDOTHELIAL CELL LOSS FOLLOWING FEMTOSECOND
LASER ASSISTED CATARCT SURGERY AND CONVENTIONAL
PHACOEMULSIFICATION IN GRADE THREE CATARACT

BY DR. TANVI JOSHI

SESSION: 2020-2023
PRIMARY DNB (1st year)
NORTHERN RAILWAY CENTRAL HOSPITAL

1
 CHIEF GUIDE
Dr O.P. Anand
Sr. Consultant (CHD)
Department of Ophthalmology,
Northern Railway Central Hospital, New Delhi

CO-GUIDE
Dr. S.K. Choudhary
Sr. Consultant (ACHD)
Department of Ophthalmology,
Northern Railway Central Hospital, New Delhi

PLACE OF STUDY
Northern Railway Central Hospital, New Delhi.

CANDIDATE
Dr. Tanvi Joshi
Primary DNB Resident

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 Contents

• Undertaking
• Abstract
• Introduction
• Review of literature
• Lacunae in literature
• Aims and objectives
• Materials and methods
• Study Performa
• References

3
 Undertaking
We agree to abide by the ethical guidelines for biomedical research on human subjects (as per
ICMR guidelines) while conducting the research project being submitted for ethical committee
considerations:
1. Project is considered to be absolutely essential for the advancement of knowledge and benefit
of all.
2. Only subjects who volunteer for the project will be included. There informed consent will
be obtained prior to commencement of the research project and subjects will be fully appraised
of all the consequences.
3. Privacy and confidentiality of the subjects shall be maintained and without the consent of
the subject no disclosure will be made.
4. Proper precautions shall be taken to minimize the risk and prevent irreversible side effects.
5. Research will be conducted by the professionally competent persons.
6. Research will be conducted in a fair, honest, impartial and transparent manner.
7. Researcher will be accountable for maintaining proper records.
8. Research will be conducted keeping in view the public interest at large.
9. Research reports, materials and data will be preserved (as per institutional guidelines).

10. Result of research will be made known through scientific publications.

11. Professional and moral responsibilities will be of the researchers, directly or indirectly
connected with the research.
12. Only those drugs which are approved by the drug controller of INDIA for a specific purpose
will be used in research project.

INVESTIGATOR- DR. TANVI JOSHI

PG-1st YEAR, OPHTHALMOLOGY
NORTHERN RAILWAY CENTRAL HOSPITAL
GUIDE - DR O.P. ANAND

CO GUIDE- Dr S.K. CHAUDHARY

4
 Abstract

This study aims to compare the efficacy of two most commonly performed techniques of
cataract surgery that is, femtosecond laser assisted cataract surgery (FLACS) and
conventional phacoemulsification (PE) in terms of minimizing endothelial cell loss,
maintaining central corneal thickness and providing better visual outcomes.

Study Design: It is a Randomised Clinical Trial and Single Centred, Stratified, Parallel Study
with Allocation ratio of 1:1.

Participants: A total of 82 patients with 41 in FLACS and 41 for PE.

Methods: It is a 18 month (Jan 2021 to June 2022) study to compare FLACS with PE over
2 month. Patient with grade III cataract will undergo PE and FLACS, done by a single
surgeon, at Northern Railway Central Hospital, New Delhi. They will be assigned in two
groups using concealed allocation method. Patient will be examined for endothelial cell loss,
central corneal both pre operatively and post operatively on day1, day7, day 30 and day 60
and this will be recorded in a preset performa.

Outcome measures:
Primary outcome-
To compare corneal endothelial cell loss by analyzing decrease in endothelial count in
absolute number per mm square using specular microscope both pre-operatively and post
operatively on day1, day7, day30 & day60.

Secondary outcome-
1.To compare central corneal thickness by analyzing increase in corneal thickness in microns
using pachymetry pre-operatively and post operatively on day1,day7,day30 &day60.
2.To compare visual acuity in post operative patients of both groups using Snellen’s chart on
day 1 and day 7.

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 Introduction
Endothelial cells are hexagonal in shape and form an inner surface of cornea with density
ranging within 2000cell/square mm to 3000cells/square mm. It is commonly affected by age,
race and genetic factors and constantly decreases by almost 0.6% per year. Having no
regeneration potential excessive loss can lead to endothelial decompensation and bullous
keratopathy. So, its integrity and assessment of functionality is valuable in evaluation of
various techniques, procedures and have many practical implications. Post operative corneal
edema after cataract surgery is a most frequent complication causing serious visual
disturbances. Factors leading to corneal edema may include phacoemulsification time, energy,
nuclear density, corneal pathology, anterior chamber depth, axial length, ocular trauma and
others.
Most frequent performed cataract surgery includes conventional phacoemulsification (PE),
being the current predominant technique and femtosecond laser assisted cataract surgery
(FLACS). Although PE provides good visual acuity and rarely causes complications, patients
expect to achieve more rapid visual rehabilitation with less ocular trauma.
Conventional Phacoemulsification(PE) introduces ultrasound to fragment and emulsify the
cataract. While incision made is smaller than extra capsular cataract extraction (ECCE), that
allows rapid visual rehabilitation, low surgery-induced astigmatism, and complication
reduction but ultrasound creates heat and damage to corneal endothelium and results in cornea
edema. Although recent advances in phacoemulsification technique and technology, such as
intraocular lens (IOL) technology, energy delivery, system fluidics and instrumentation, made
cataract surgery more and more safe and efficient . Despite these advances, sight-threatening
complications, including postoperative corneal edema still occur.
Recent introduction of femtosecond laser assisted cataract surgery (FLACS) ,in 2009 by Nagy
et al, provides advantage like self-sealing, clear corneal incisions, and arcuate incisions, lens
fragmentation using different patterns, anterior circular capsulotomy, lens softening as well.
This technique introduced a high resolution anterior chamber imaging system with a
femtosecond laser, which provide short pulses (10−15 s) at a near infra red wavelength and at
specific areas in anterior chamber thus creating a micron incision disruption in tissue and thus
less collateral damage in ocular tissue.
Nuclear fragmentation with femtosecond assisted laser before PE, shows reduction in effective
phacoemulsification time (EPT) and amount of cumulative dissipated ultrasound energy(CDE),
significantly, as stated by numerous intial studies. This reduction in both time and energy is
known to results in lower mechanical trauma from sonic waves and thermal induced injury thus
reducing intra-operative corneal endothelial cell loss and improved postoperative corneal
edema. Due to this decrease, FLACS is postulated to be beneficial in reduction of endothelial
injury altogether, it can provide less risk of complications, shorter recovery period and better
visual outcomes.
Recent more advancement in modes of FLACS machine, improving the efficacy of the
procedure in terms of increased precision, better reproducibility, better wound architecture,
improved accuracy and efficacy, further reducing the need of phacoenergy . While providing a
theoretical benefit that FLACS for patient with dense cataract or pre operative decrease in
endothelial cell loss can be favourable, still a large sample size with long follow up can provide
more evidence for it. With that in mind a comparative study aiming to record endothelial cell
loss and central corneal thickness post operatively after FLACS and PE will be conducted to
examine if lower required energy in FLACS is beneficial on long term.
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 Review of literature

Daliya dzhaber, et al performed a randomized controlled clinical trial in 2018

Comparing the changes in corneal endothelial cell density and central corneal thickness
between conventional and femtosecond laser-assisted cataract surgery followed 134 eyes
of 67 patients for 3 month, found pre and post operative corneal endothelial cell density and
central corneal thickness were not significantly different between femtosecond laser associated
cataract surgery and conventional phacoemulsification surgery.

Jai kelkar,et al in their prospective comparative study in 2020 on endothelial cell loss and
morphology after femtolaser assisted cataract surgery and phacoemulsification compared
a total of 187 eyes found a significant decline in endothelial cell count in both groups at post
operative 15 day, but stable in further visit (8% decline in phaco vs.7.7% decline in femto,
p=0.87) till 6 month. Also, they found that, with higher endothelial cell count, a high cell loss
was recorded at 6 month.

Therese kraup, et al in a 2019 prospective randomised trial with 6 month of follow up on

Comparison of refractive predictability and endothelial cell loss in femtosecond laser
assisted cataract surgery and conventional phaco surgery asserted that endothelial cell loss
was significantly lower in FLACS compared to PE at 40 and 180 days (p=0.036).They found
a 30% reduction in endothelial cell loss at day40 in FLACS compared to CPS and a 21%
reduction at day 180 which showed promising results.

Muhammad saim khan ,et al performed a randomized control trial on Effect of FLACS
on Endothelial Cell Count in 2017 found FLACS to be safe and effective surgical technique
and found statistically significant difference of p=0.001 in endothelial cell count when
compared between FLACS and PE in 4 week follow up.

Ina Conrad et al in there, Corneal endothelial cell loss and corneal thickness in
conventional compared with femtosecond laser assisted cataract surgery, a prospective
randomized intra individual cohort study of 2013, stated significant reduction in
endothelial cell count and central corneal thickness more in FLACS when compared to PE at
follow up of 1 day, 1 week and 3 month. They concluded that FLACS might be beneficial in
conditions with low preoperative endothelial cell values.

Lucia bascaran ,et al studied Differences in energy and corneal endothelium between
femtosecond laser assisted and conventional cataract surgeries, a prospective,
randomized controlled trial in 2017 stated no significant differences in endothelial cell
groups and central corneal thickness between both groups .They concluded FLACS displaying
significant improvement in phacoemulsification parameters in comparison to conventional
phacoemulsification.

Therese kraup et al in a prospective consecutive cohort conducted in 2014 on Endothelial

cell loss and refractive predictability in femtosecond laser assisted cataract surgery
compared with conventional cataract surgery stated no significant difference in endothelial
cell loss (p=0.30) and refractive predictability between FLACS and PE 3 month
postoperatively.
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Edyta chlasta-twardzik et al performed a prospective randomized comparative
observational case control study on Comparison of the selected parameters of the anterior
segment of the eye between femtosecond laser assisted cataract surgery, micro incision
cataract surgery(MICS) and conventional phacoemulsification(PE) in 2019 found a
significant reduction in endothelial cell loss percentage in FLACS group over postoperative 7 th
day (p=0.005), 1 month (0.002) and 6 month (<0.001) when compared to MICS and PE. There
was a statistically significant raised central corneal thickness in MICS compared to FLACS
and PE (p=0.002) on 7th post operative day; although no significant difference was seen on 6
month follow up.

Zi Ye et al in A Meta analysis comparing postoperative complications and outcomes of

femtosecond laser assisted cataract surgery versus conventional phacoemulsification for
cataract performed in 2016 analysed a total of 9 trials found that although corneal endothelial
cell loss was not significantly reduced but there was a trend towards a lower cell loss after
FLACS (p=0.05).

Xiaoyun Chen et al, in Efficacy and safety of femtosecond laser assisted cataract surgery
versus conventional phacoemulsification for cataract, a meta analysis of randomized
controlled trials with 9 qualified studies involving 989 eyes found a pooled data showing
slight higher corneal endothelial cell count in FLACS than PE at day 1 post operative
(p=0.020), but no significant difference after 7 day follow up or longer. Central corneal
thickness was significant lower in FLACS than PE (p=0.020) at post operative day 1 but no
significant results after 7 day follow up concluding FLACS causing less damage to cornea and
swelling.

Agnes I. Takacs et al in 2012 performed a comparative study on Central corneal volume

and endothelial cell count following femtosecond laser assisted refractive cataract surgery
compared to conventional phacoemulsification studied central corneal thickness significant
higher in the phaco group than FLACS on post operative day1 but no significant results in
further follow up. They also studied endothelial cell counts and stated that they were lower in
phaco group at all post operative follow up but that was not statistically significant.

H Ranjini et al in a 2017 comparative study on Femtosecond laser assisted cataract

surgery versus 2.2 mm clear corneal phacoemulsification stated reduction in endothelial
cell count postoperatively in both group with cell density decreasing more in FLACS than in
CPS group(p=0.032) but pachymetry was not statistically significant in both groups. Thus
concluding that reduction in both groups does not have a morphologically measurable effect
and is not clinically significant.

Xinyi Chen et al, in a 2016 meta analysis on Comparing the curative effects between
femtosecond laser assisted cataract surgery and conventional phacoemulsification
surgery compared FLACS and PE over 9 randomized controlled trial and 15 cohort study
found that the mean endothelial cell loss percentage in FLACS was significantly lower in PE
group at 7th postoperative day (p=0.03), 1 month (p<0.01), 3 month (p=0.03). Central corneal
thickness was also significantly lower in FLACS than PE at postoperative 7th day, 1 month and
3-6 month. They found FLACS safer and effective in reducing endothelial cell loss and
maintaining central corneal thickness.

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 Lacunae in literature

The laser in Femtosecond laser assisted cataract surgery (FLACS) generates high energy
plasma by using femto second pulse of energy with help of photodisruption ensuring decrease
of phacoenergy . Being a relatively new technique , it is theoretically hypothesized that
decrease consumption of time and energy, it can decrease endothelial cell loss and maintain
corneal transparency. Also with wide availability, advancement and better use of new models
of FLACS machine there are only limited studies on this technique , especially in Indian
setting. Moreover, the referenced studies conclude with mixed reviews; few are sharing
better results while other shared no advancement, hence more research is necessary to
validate this finding. Since a globally uniform policy of using femtosecond laser or
conventional phacoemulsification, is not stipulated and there is less experience with use of
FLACS method, this technique can be further studied and brought into routine practices.

Justification for study:

After cataract surgery fast visual recovery and corneal structural integrity and functionality
are expected. Past studies, shows increase usage of ultrasound energy and time in
phacoemulsification technique creating heat and damage to corneal endothelium and results
in cornea edema. As phaco energy can be decreased in FLACS ; it is considered that it might
reduce endothelial cell loss . It is therefore important to see whether FLACS can provide
equal efficacy and better safety profile providing improved outcomes.. Also there are very
few studies assessing the efficacy of femtosecond laser assisted technique on minimizing
endothelial cell count.

Research question:
Is Femtosecond laser assisted cataract surgery more efficacious in minimizing endothelial
cell loss and provides better visual outcomes in comparison to conventional
phacoemulsifiaction technique?

Hypothesis
Femtosecond laser assisted cataract surgery is more effective in terms of minimizing
endothelial cell loss, maintaining central corneal thickness and providing better visual
outcomes compared to conventional phacoemulsification.

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 Aim & Objectives

Aim:

Comparative evaluation of corneal endothelial cell loss following femtosecond laser

assisted cataract surgery and conventional phacoemulsification in grade three cataract.

Objectives:

Primary objective:
• To compare corneal endothelial cell loss by analyzing decrease in endothelial count in
absolute number per mm square using specular microscope both pre-operatively and post
operatively on day1, day7, day30 & day60.

Secondary objective:
• To compare central corneal thickness by analyzing increase in corneal thickness in microns
using pachymetry pre-operatively and post operatively on day1,day7,day30 &day60.
• To compare visual acuity in post operative patients of both groups using Snellen’s chart on
day 1 and day 7.

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 Materials and Methods

• Study Site: OPD of Ophthalmology Department, Northern Railway Central Hospital, New
Delhi.
• Study Population: Patients will be selected from OPD of Ophthalmology Department
(Railway Beneficiary) on the basis of eligible criteria.
• Case definition-The study will include patients with grade III (LOCS-III grading) of cataract
that underwent FLACS &PE and they will be compared for endothelial cell count. All
surgeries in consideration for study shall be performed by the same surgeon at the Northern
Railway Central Hospital, New Delhi.
• Study period: 18 month (Jan 2021 to June 2022).
• Study Design: It is a randomised clinical trial and a single centred study. It is a stratified (age
group 40-80 years), parallel study with allocation ratio of 1:1.
• Sample size: Assuming minimum 5% significance level and 95% confidence level the base
value for sample size was calculated as per the study conducted by Jai kelkar et al wherein,
difference of mean values of two groups (FLACS & PE) at 2 month of surgery for endothelial
cell count loss were 168 and standard deviation is 270 (FLACS=2631+378 &
PE=2463+270). With the above reference/assumptions and a margin of error (confidence
interval) of +10%, minimum power of 80% and detecting a two sided study with p value of
0.05 the sample size will be calculated as 41 eyes per group for the study.
Proposed sample size for the study include total of 82 eyes (41 per group), including 10%
attrition rate.
Formula used: N=2 σ² (Z1−α/2+Zπ) ² Δ2 /
Where:
Z1−α/2= percentile of the normal distribution used as the critical value in a two-tailed test
(1.96)
Zπ = percentile of the normal distribution where π is the power of the test (0.84 for 80th
percentile)
σ = within-group standard deviation
Δ = expected mean difference between the treatment versus control population

• Patient selection:
Inclusion Criteria-
All consecutive patients who met all the following criteria, will be included:
• Grade III nuclear sclerosis (LOCS)
• Patients of 40-80 years of age.
Exclusion Criteria-
• Co-existing corneal opacity or any previous ocular surgery .
• Co-existing macular pathology or any serious ocular disease.
• Previous history of any ocular infection.
• Glaucoma.
• Deep seated eye.
• Patients with neck and back rigidity.
• Pediatric cataract
• Traumatic cataract.
• Complicated cataract.
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Methodology
Pre-operative evaluation
Patient advised for cataract surgery and IOL implantation by consultant ophthalmologist, will
be subjected for recruitment in the study as per inclusion and exclusion criteria and after
giving their consent. Pre-op full ophthalmologic examination will be done on each patient,
including visual acuity with Snellen’s chart, intraocular pressure recorded via non-contact
tonometer (Shin Nippon), endothelial cell count using specular microscope (Tomey) and
central corneal thickness using pachymeter with specular microscope (Tomey), keratometry,
axial length, IOL power calculation and the formula using optical biometry (Tomey). Patient
is dilated with dilator drop (Tropicamide (0.8%), Phenylephrine hydrochloride (0.5%)) to
examine complete anterior segment & posterior segment examinations with slit lamp
biomicroscopy and fundus status with 90 D lens. Lens opalescence will be graded via The
Lens Opacities Classification System (LOCS) III grading score. Other investigations like
blood sugar fasting and post prandial and ECG are done. Baseline parameters will be
recorded in a preset proforma.
Randomisation
After informed, written and explained consent given from the patient, they will be allotted in
one of the two assigned operation method by concealed allocation method. Herein, 41 piece
of paper will be marked FLACS and other 41 will be marked PE. They will be then put inside
in an opaque sealed envelopes. On the cover of all envelopes number 1 to 82 will be written
accordingly. On the day of surgery, a computer generated random number table will assign a
number and that number envelope will be opened, by an OT assistant. Envelope with the type
of operating method written on them will be given to the surgeon.
Procedure
After confirming patient fit for surgery, patient is advised for eye drop (moxifloxacin(0.5%) ,
Ketorolac trimethamine (0.5 %) pre operatively one day prior to surgery. On the day of surgery,
patient is dilated with Tropicamide (0.8%), Phenylephrine hydrochloride (0.5%). The surgeon
will be given an envelope and the surgery commences.
Patient for FLACS will be made to lie down flat on table under AMO FLACS machine.
Operating eye will be docked; anterior segment imaging performed and vacuum created.
Rhexis size, nuclear fragmentation (4/6 pieces) and corneal incision (site and size) selected.
Femto laser will be fired and vacuum released. The patient is shifted to another table having
STELLARIS-PC Phaco machine (B n L) and microscope. Here the patient is given topical
anesthesia having 4% lignocaine and 5% povidone-iodine solution is instilled into the
conjunctival sac to make it sterile. A self-adhesive, sterile plastic drape will be used around the
eyelids and the eyelashes are excluded from the operative field. A self-retaining speculum to
hold the lids open will be inserted. Primary incision is created by 2.8mm keratome (if not made
with laser),anterior capsule rhexis is removed and hydration done by cannula. After that
viscoelastic will be instilled and phaco probe inserted to aspirate the cortex. Residual cortical
matter is aspirated manually using a two-way irrigation-aspiration cannula or an auto mated
irrigation-aspiration probe. A posterior chamber intraocular lens (B n L) is then implanted in
the bag. Residual viscoelastic will be aspirated at the end of surgery. After ensuring wound
integrity eye is patched after instilling vigamox 0.5%.
In cases where the patients are operated by conventional phacoemulsification, the patient
is given topical anesthesia (4% lignocaine). After that 5% povidone-iodine solution will be
instilled into the conjunctival sac and, self-adhesive sterile plastic drape is applied to the skin
excluding eyelid and eyelashes from the operative field and inserting a self-retaining speculum
to hold the lids open. A main port will be created using a keratome and one or two

12
 side ports will be made for bimanual control using a lanceolate knife such as an MVR or 15°
blade. The anterior chamber is filled with an ocular viscosurgical device (OVD)—previously
termed viscoelastic.After injecting viscoelastic in the anterior chamber, the anterior capsule of
the lens will be opened (capsulotomy). An initial nick is made with a bent 26 gauge disposable
needle and the capsulotomy completed by multiple perforations in a circular pattern (can
opener), superior linear or curved opening (endo-capsular envelope technique), or the flap is
torn off in a continuous curvilinear fashion (continuous curvilinear capsulorhexis) using either
the bent 26 gauge disposable needle, an irrigating cystotome or a capsulorhexis forceps to tear
the capsule. Trypan blue dye will be used to stain the lens capsule for better visibility. A bubble
of air is injected in the anterior chamber, a few drops of Trypan blue dye is injected underneath
the air bubble on the anterior lens capsule and spread evenly on the surface to stain. The air
and residual dye are irrigated out of the eye using BSS and then replaced with viscoelastic to
fill the anterior chamber before capsulorhexis. After completing the capsulotomy, a fine, 27
gauge blunt- tipped cannula is used to inject BSS under the lens capsule to separate the cortex
from the capsule. This is termed hydro- dissection. Phaco probe is inserted and nucleus
aspirated. Residual cortical matter is aspirated manually using a two-way irrigation-aspiration
cannula or an auto mated irrigation-aspiration probe. A posterior chamber intraocular lens (B
n L)is then implanted in the bag.Residual viscoelastic will be aspirated at the end of surgery.
After ensuring wound integrity eye is closed with 0.5%viagmox.
Post-operative evaluation
The patient will be called post operatively on Day 1, Day 7, Day30 and Day 60 and vision
will be recorded using Snellens chart, intraocular pressure recorded via non contact
tonometer (Shin Nippon), endothelial cell count and central corneal thickness via
pachymetry will be measured using specular microscope with inbuilt pachymeter (Tomey
model EM- 4000). Slit lamp examination to assess conjunctiva, cornea, anterior chamber,
pupil, implanted IOL and fundus examination using 90D will be done on every visit. All the
parameters will then be recorded in the proforma at every visit.
Statistical analysis
The statistical analysis will be performed using online software.The data collected would be
analysed and categorical variables will be presented in number and percentage(%) and
continuous variables will be presented as mean ± SD for relevant comparisons.Results will be
presented in form of tables and graphs.
Statistical tests are expected to be applied as follows:
i. The comparative analysis between groups would be done by applying chi square test and
student t test.
ii. Any other test as applicable at the time of analysis will be considered.
p value less than 0.05 considered as significant at 95% confidence level.

Ethical Considerations
This study will be conducted in accordance with the tenets of the Declaration of Helsinki,2008.
Preoperatively, all patients shall be informed about the risks and possible complications of the
operations, the post-operative management & the study in which they shall be participating and
written informed consent shall be obtained from all patients.
All the procedures which will be carried out in the study are being routinely performed in
Northern Railway Central Hospital, New Delhi. This study will not render the subject to
additional risk. It will be conducted on the ethical guidelines for biomedical research on human
subjects as given by Central Ethics Committee on Human Research (CEHER), ICMR, New
Delhi, 2017 and CONSORT guidelines,2010 are followed.

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 Study flow diagram
Enroll patient on the basis of inclusion and exclusion
criteria. Enrolment
Take informed andbasis
on the written consent. and
of inclusion

Record baseline visual parameters as visual acuity, intraocular pressure, endothelial

cell count, central corneal thickness, grading of cataract and general ocular
examination. Note down these parameters on a preset proforma

.
Allocate in two groups via concealed allocation method.

Femtosecond laser Conventional

assisted catarct surgery phacoemulsification (PE)
(FLACS)

Pupil will be dilated with eye drop
[Tropicamide (0.8%), Phenylephrine
hydrochloride (0.5%)] and topical anaesthesia
Proparacaine 0.5% will be instilled before
surgey. After this patient is made to lie on table
and using AMO FLACS machine, eye will be
docked, vacuum created to create corneal
incision ,capsulotomy and lens fragmentation.
Vacuum is released and patient is made to lie
on STELLARIS-PC phaco machine , after
which hydro dissection will be done , and
foldable IOL will be implanted in the capsular
bag.
Pupil will be dilated with eye drop
[Tropicamide (0.8%), Phenylephrine
hydrochloride (0.5%)] and topical anaesthesia
Proparacaine 0.5% will be instilled prior to
suregry. After this, surgery will be performed
using STELLARIS PC phaco machine system
wherein a main port and one to two side port
will be created followed by capsulotomy and
capsulorhexis . After, hydrodissection is done
and upon completion, IOL will be implanted in
capsular bag.

Post operatively visual acuity, intraocular pressure, endothelial cell count and central
corneal thickness will be assessed on day 1, day 7, day 30 and day 60 and noted .

Stastistical analysis of data and results.

14
 Proforma for study
COMPARATIVE EVALUATION OF CORNEAL ENDOTHELIAL CELL LOSS
FOLLOWING FEMTOSECOND LASER ASSISTED CATARCT SURGERY AND
CONVENTIONAL PHACOEMULSIFICATION IN GRADE THREE CATARACT
• Date
• Patient’s Name:
• ID NO:
• Age/Sex:
• Eye:
• Full postal address:
• Telephone No:
• Procedure done:

Ocular examination (concerned eye)

Pre op Post-op Post-op Post-op Post op

Day 1 Day 7 Day 30 Day 60
Visual acuity

IOP

K1/K2

Endothelial cell
count
Central corneal
thickness
Cornea

Conjunctiva

Anterior chamber

Pupil

Lens

Fundus

15
 References
1. Dzhaber D, Mustafa O, Alsaleh F, Mihailovic A, Daoud YJ. Comparison of changes in
corneal endothelial cell density and central corneal thickness between conventional and
femtosecond laser-assisted cataract surgery: a randomised, controlled clinical trial. British
Journal of Ophthalmology. 2020 Feb 1;104(2):225-9.
2. Kelkar J, Kelkar A, Pandit A, Kelkar S. A prospective comparative study on endothelial
cell loss and morphology after femtolaser-assisted cataract surgery and
phacoemulsification. International Ophthalmology. 2020 Feb 8:1-7.
3. Krarup T, Ejstrup R, Mortensen A, La Cour M, Holm LM. Comparison of refractive
predictability and endothelial cell loss in femtosecond laser-assisted cataract surgery and
conventional phaco surgery: prospective randomised trial with 6 months of follow-up. BMJ
Open Ophthalmology. 2019 Mar 1;4(1):e000233.
4. Khan MS, Habib A, Ishaq M, Yaqub MA. Effect of femtosecond laser-assisted cataract
surgery (FLACS) on endothelial cell count. J Coll Physicians Surg Pak. 2017 Dec
1;27(12):763-6.
5. Conrad-Hengerer I, Al Juburi M, Schultz T, Hengerer FH, Dick HB. Corneal endothelial
cell loss and corneal thickness in conventional compared with femtosecond laser–assisted
cataract surgery: three-month follow-up. Journal of Cataract & Refractive Surgery. 2013
Sep 1;39(9):1307-13.
6. Bascaran L, Alberdi T, Martinez-Soroa I, Sarasqueta C, Mendicute J. Differences in energy
and corneal endothelium between femtosecond laser-assisted and conventional cataract
surgeries: prospective, intraindividual, randomized controlled trial. International journal of
ophthalmology. 2018;11(8):1308.
7. Krarup T, Morten Holm L, la Cour M, Kjaerbo H. Endothelial cell loss and refractive
predictability in femtosecond laser‐assisted cataract surgery compared with conventional
cataract surgery. Acta ophthalmologica. 2014 Nov;92(7):617-22.
8. Chlasta-Twardzik E, Nowińska A, Wylęgała E. Comparison of the selected parameters of
the anterior segment of the eye between femtosecond laser-assisted cataract surgery,
microincision cataract surgery, and conventional phacoemulsification: A case-control
study. Medicine. 2019 Dec;98(52).

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9. Ye Z, Li Z, He S. A meta-analysis comparing postoperative complications and outcomes
of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification for
cataract. Journal of Ophthalmology. 2017 Apr 30;2017.
10. Chen X, Xiao W, Ye S, Chen W, Liu Y. Efficacy and safety of femtosecond laser-assisted
cataract surgery versus conventional phacoemulsification for cataract: a meta-analysis of
randomized controlled trials. Scientific reports. 2015 Aug 13;5:13123.
11. Takács ÁI, Kovács I, Miháltz K, Filkorn T, Knorz MC, Nagy ZZ. Central corneal volume
and endothelial cell count following femtosecond laser–assisted refractive cataract surgery
compared to conventional phacoemulsification. Journal of refractive surgery. 2012 Jun
1;28(6):387-91.
12. Ranjini H, Murthy PR, Murthy GJ, Murthy VR. Femtosecond laser-assisted cataract
surgery versus 2.2 mm clear corneal phacoemulsification. Indian Journal of
Ophthalmology. 2017 Oct;65(10):942.
13. Chen X, Chen K, He J, Yao K. Comparing the curative effects between femtosecond laser-
assisted cataract surgery and conventional phacoemulsification surgery: a meta-analysis.
PLoS One. 2016 Mar 21;11(3):e0152088.
14. Parsons disease of eye 22nd edition page no 272,273,274
15. Aly MG, Shams A, Fouad YA, Hamza I. Effect of lens thickness and nuclear density on
the amount of laser fragmentation energy delivered during femtosecond laser–assisted
cataract surgery. Journal of Cataract & Refractive Surgery. 2019 Apr 1;45(4):485-9

17
Protocol No: IEC-NRCH/DNB/Protocol/2021/11
Comparative evaluation of corneal endothelial cell loss
1. Title of Study following femtosecond laser assisted cataract surgery and
conventional phacoemulsification in grade three cataract
2. Name and Designation of Dr. Tanvi Joshi, Primary-DNB resident in Ophthalmology.
Principal Investigator (PI)
3. Address and email of PI House no. 10, Preet vihar, Bhaniawala, dehra dun-248140
tanviravijoshi04@gmail.com
4.Name(s) of Co- NA
investigators, designations
and departements
Signature
5. Guide Name, Designation
and Department. (including Dr O.P. Anand
email) Sr. Consultant (CHD)
Department of Ophthalmology,
Northern Railway Central Hospital, New Delhi
drop.anand@yahoo.com
Signature

Dr. S.K. Choudhary

6.Co-Guide names, Sr. Consultant (ACHD)
Designation and Department Department of Ophthalmology,
Northern Railway Central Hospital, New Delhi
shailenderchoudhary@rediffmail.com
7.Place of study Northern Railway Central Hospital, Basant lane, New Delhi
8.Duration of study 18 month study (Jan 2021 to June 2022)
9.Type of study Randomised Clinical Trial and single center study in
Northern Railway Central Hospital
10. Brief description of the
proposal
To compare corneal endothelial cell loss percentage by
Objective 1. analysing decrease in endothelial count in absolute number
per mm square using specular microscope both pre and post
operatively on day1,day7,day30 & day60.

Objective 2. To compare central corneal thickness by analyzing increase

in corneal thickness in microns using pachymetry pre and
post operatively on day1,day7,day30 & day60.

Objective 3. To compare visual acuity in post operative patients of both

groups using snellen’s chart on day 1 and day 7.

After cataract surgery fast visual recovery and corneal

11. Justification of the study
structural integrity and functionality are expected. Past
studies, shows increase usage of ultrasound energy and time
in PE creating heat and damage to corneal endothelium and
results in cornea edema. As phaco energy can be decreased
18

12. Methodology including
study design, control(s), drugs
to be used and dosage,
duration of treatment and
investigations to be done.
13. Number of subjects and Proposed sample size for the study include total of 82 eyes
rationale for that (41 per group).
14. Inclusion criteria • Grade III nuclear sclerosis (LOCS)
• Patients of 40- 80 yrs of age.
15. Exclusion criteria
16. Permission from DCG(I),
I f applicable on any other
regulatory authority.
17. If a questionnaire or
proforma is being used which
has copyright
18. If any work had been
started on the project
19. How will the
confidentiality be maintained
of the participants?
in FLACS; it is considered that it might reduce endothelial
cell loss. It is therefore important to see whether FLACS can
provide equal efficacy and better safety profile providing
improved outcomes.
Eye will be graded using LOCS III grading and will be
selected for surgery by the treating consultant. After which
endothelial cell count, central corneal thickness and visual
acuity will be compared at pre-op and post-op day 1, day7,
day 30 and day 60.
• Co-existing corneal opacity or any previous ocular
surgery.
• Co-existing macular pathology or any serious
ocular disease.
• Previous history of any ocular infection.
• Glaucoma.
• Deep seated eye.
• Patients with neck and back rigidity.
• Pediatric cataract
• Traumatic cataract.
• Complicated cataract.
No Yes
If applicable, date of permission.
If permission is obtained to use such proforma/questionnaire
Is to be attached.
Yes No
(A separate certificate/ undertaking is to be given for this )
The data obtained from this study will be analysed and can
be viewed by only authorized persons like principle
investigator, study personnel and the ethics committee and
regulatory authorities or any person or agency if required by
law. Your personal details, history and other medical
information will be kept in close confidentiality by the
principle investigator. The information from this study, if
published in scientific journals or presented at clinical
meetings, will not reveal your identity. Your identity will be
kept completely anonymous during or after study.
19
 20. Risk involved to the
participants
21. Safety measures for the
proposed intervention or
investigation
22. If there is deviation from
standard therapy give detail
23. Plans for coverage of
medical risk (s) during the
study
24.Total Budget of the study
How the cost of drug,
investigation, implant or
device will be met.
25. Patient information Sheet
Mark √ if attached
No additional risk
No additional risk..
Not applicable
No additional risk.
The participation in the project will not add/ incur
extraordinary expenditure on the patient, investigations like
Blood Investigations, OCT are available in the hospital and
the cost will be borne by railway administration.
English version
Hindi version

English version
26. Patient consent form Hindi version
Mark √ if attached Exemption from obtaining consent. NA.

27. Conflict of interest for any Not applicable.

other investigator(s),
If so, please explain in brief.
28. Other documents as 6. Undertaking about who will bear the cost in case of
applicable
1. Covering letter through proper channel with approval of
head of the concerned department.
2. Copy of the complete protocol with all details
3. Brief CV of the principal investigator and co-
investigators with number of projects with PI
4. Investigator’s Brochure
5. Undertaking that the study will be performed according
to ICMR and GCP guidelines.
project related injury.
7. In case an insurance cover is intended, an insurance
certificate must be provided. (As per ICMR guidelines)
8. In case of multi-centric study, a clearance for IEC of those
centres must also be obtained and enclosed.
9. Investigator shall submit clear plan for disposal of
biological/chemical waste or leftover sample.
10. Documents as mentioned in column 16,17,18,25 and 26
are to be attached.

We, the undersigned, have read and understood this protocol and hereby agree to conduct the
study in accordance with this protocol and to comply with all requirements of the ICMR
guidelines (2017)

Signature of the Investigators: Place Date

Signature of the Head of the Department Place Date
20
 SOP-NRCH-IEC Annexure 8
Institutional Ethics Committee (NRCH-IEC)
PARTICIPANT INFORMED CONSENT FORM (PICF)

Protocol Study number: IEC-NRCH/DNB/Protocol/2021/11

Patient identification number:

Title of the project: Comparative evaluation of corneal endothelial cell loss following
femtosecond laser assisted cataract surgery and conventional phacoemulsification in grade
three cataract
Name of Principal investigator: Dr.Tanvi Joshi Tel. No: 8171207536

The contents of the information sheet dated__________ that was provided have been read
carefully to me /explained in detail to me, in a language that I comprehend, and I have fully
understood the contents. I confirm that I have had the opportunity to ask questions.

The nature and purpose of the study and its potential risks / benefits and expected duration of
the study, and other relevant details of the study have been explained to me in detail. I
understand that my participation is voluntary and that I am free to withdraw from the study at
any time, without giving any reason, without my medical care or legal right being affected.

I understand that the information collected about me from my participation in this research and
sections of any of my medical/health record may be looked at by the responsible persons of the
hospital, the ethics committee and the regulatory authorities for the current study and any
further research that may be conducted in relation to it. I give permission for these individuals
to have access to my records.

I understand that my identity will not be revealed to third parties or published.

I agree not to restrict the use of any data or result that arise from the study provided such use
is only for scientific purpose.
I agree to take part in the above study.

(Signatures / Left Thumb Impression) Date Place:

Name of Participant: Son/Daughter/spouse of:

Complete postal address:

This is to certify that the above consent has been obtained in my presence

Signatures of the Principal Investigator Date Place:

Witness – 1 Witness – 2
Signature Signature
Name: Name:
Address: Address

21
 शोध में भाग लेने के ललए सहमलि पत्र

शोध प्रोटोकॉल न०: IEC-NRCH/DNB/Protocol/2021/1

शोध भागी पहचान न०:

शोध का शीर्षक: फेम्टोसेकन्ड लेज़र अससस्टे ड कैटरे क्ट सर्जरी और कन्वेंशनल फेकोएमुल्सिसफकेशन
द्वारा ग्रे ड III मोसियास िंद के ऑपरे शन के ाद कॉसनजया के एिं डोथेसलअल सेल में होने वाले घटाव का
िुलनात्मक मूल्ािंकन

शोधकर्ता डत०कत नतम:Dr. Tanvi Joshi मोबतइल न०:8171207536

ऊपर लिखे शोध के सम्बंध में बताने के लिए मुझे जो पेशट

ें इन्फारमेशन शीट सं०…………….. दी गई है,
उसमें लिखी सभी जानकारी मुझे अच्छी तरह से समझ में आ गई है । इस शोध में की जाने वािी जॉचों,
इिाज और मेरे बारे में जो भी जानकारी िी जाएगी उस सबसे मुझे पूरी तरह अवगत करा ददया गया है।
इस शोध के उद्दे श्य, ककए जाने के तरीके, इस के दौरान सम्भाववत िाभ एवं हानन और इसे करने वािे
डाक्टरों के बारे में मुझे पूरी तरह से मेरी भाषा में अच्छी तरह से समझा ददया गया है और मैं इन सबसे
भिी भााँनत अवगत हूाँ।
मैं इस से अवगत हूाँ कक इस शोध में भाग िेना पूरी तरह स्वैच्च्छक है। मेरा इस शोध में भाग िेना या इसे
बीच में छोड़ देना ककसी भी प्रकार से मेरे अस्पताि में ककए जा रहे इिाज या भववष्य में अस्पताि में
इिाज की सुववधा के अधधकार को प्रभाववत नहीं करे गा। इस शोध में भाग िेना या न िेना पूरी तरह मेरी
इच्छा पर है।
मैं इस तथ्य से अवगत हूाँ कक इस शोध में मेरे बारे में जो भी जानकारी एकत्र की जाएगी वह इस शोध से
सम्बंध रखने वािे अस्पताि के और सम्बंधधत संस्थाओं के च्जम्मेदार िोगों को जो मरीज के प्रनत अपना
दानयत्व अच्छी तरह समझते हैं, दी जा सकती है। मैं इसके लिए अपनी सहमनत दे ता/ दे ती हूाँ।
मैं समझता हूाँ / समझती हूाँ कक मेरी पहचान न प्रकालशत की जाएगी और न अन्य िोगों को जो इस सबसे
सम्बंधधत नहीं हैं,बताई जाएगी।
मैं इस शोध से प्राप्त होने वािे ककसी भी तथ्य या ननष्कषष को वैज्ञाननक उद्दे श्य के लिए प्रयोग करने में
ककसी भी प्रकार की बाधा नहीं करने के लिए सहमत हूाँ।
मैं इस शोध में भाग िेने के लिए सहमत हूाँ।

शोध में भाग िेने वािे व्यच्क्त के हस्ताक्षर/बाएाँ अंगठ

ू े का ननशान:
नाम: पत्र
ु /पत्र
ु ी/पत्नी

22
पता:

मोबाइि:

मैं प्रमाणित करता हूाँ कक उपरोक्त सहमनत मेरी उपच्स्थनत में िी गई है।

मख्
ु य शोधकताष के हस्ताक्षर:
गवाह 1: गवाह 2:
हस्ताक्षर: हस्ताक्षर:
नाम: नाम:
पर्त: पर्त:
SOP-NRCH-IEC Annexure 9
PARTICIPANT INFORMATION SHEET (PIS)
Dear sir/madam,
You are hereby invited to be part of proposed research entitled
COMPARATIVE EVALUATION OF CORNEAL ENDOTHELIAL CELL LOSS
FOLLOWING FEMTOSECOND LASER ASSISTED CATARCT SURGERY AND
CONVENTIONAL PHACOEMULSIFICATION IN GRADE THREE CATARACT

The proposed study will be conducted in Northern Railway Central Hospital, New Delhi. The
information in this document is to help you decide whether or not to participate in the present
study. You will be one of the participants we plan to recruit in this study.

Title of the study: COMPARATIVE EVALUATION OF CORNEAL ENDOTHELIAL

CELL LOSS FOLLOWING FEMTOSECOND LASER ASSISTED CATARCT SURGERY
AND CONVENTIONAL PHACOEMULSIFICATION IN GRADE THREE CATARACT

Aims and method of study:

• To compare corneal endothelial cell loss percentage by analysing decrease in
endothelial count in absolute number per mm square using specular microscope both
pre and post operatively on day1, day7, day30 &day 60 .
• To compare central corneal thickness by analyzing increase in corneal thickness in
microns using pachymetry pre and post operatively on day1, day7, day30 &day 60.
• To compare visual acuity in post operative patients of both groups using snellen’s chart
on day 1 and day 7.
Procedure
Since you have been diagnosed with cataract and will be operated by, the treating
ophthalmologist so we are including you in the study. After filing consent for your
participation in the study you will be alloted one of the two operative procedures via
concealed allocation method and then it will not be your choice to choose an operative
23
 procedure. After allotment, then we will examine your visual acuity, IOP, endothelial cell
count using specular microscope , central corneal thickness using pachymetry in built of
specular microscope and general ocular examination on slit lamp. Your IOL power will be
calculated and pre-operative medications will be explained. After which you will be asked
to pick one envelope containing one of the technique for surgery. Both these techniques
,will be thoroughly explained to you and are well known surgical techniques being used
routinely. Difference lies in the initial steps of surgery i.e rhexis and nucleus spliting is
done via laser in FLACS and manually by the operating surgeon in PE. Rhexis means
removing a layer of capsule in which your lens is placed so that the diseased lens could be
taken out.. Rest of the steps are same.All the above parameters, including visual acuity, iop,
endothelial cell count and central corneal thickness would be noted before surgery and
after surgery at day1, day 7, day 30 and day 60 on a preset performa.
Expected duration of subject participation: 2 months
The benefits to be expected from the research to the subject or to others:
As such there is no assurance of any benefit during the study duration; the management will be
done as per routine hospital protocols. But this study might help in gaining knowledge that may
help in better management of such patients in future.
Any risk of subject associated with the study: No additional risk.
Maintenance of confidentiality of records:
The data obtained from this study will be analysed and can be viewed by only authorized
persons like principle investigator, study personnel and the ethics committee and regulatory
authorities or any person or agency if required by law. Your personal details, history and other
medical information will be kept in close confidentiality by the principle investigator. The
information from this study, if published in scientific journals or presented at clinical meetings,
will not reveal your identity. Your identity will be kept completely anonymous during or after
study.
Provision of free treatment for research related injury: Not applicable
Compensation of subjects for disability or death resulting from such injury: Not
applicable
Freedom of individual to participate and to withdraw from research at any time without
penalty or loss of benefits to which the subjects would otherwise be entitled
You shall be required to sign a form for informed consent to participate in the research work
which shall be signed by the treating doctor as well. You would be required to sign a copy of
information sheet after writing “I have been given a copy of information sheet”, which would
be kept by the doctor and a copy will be given to you. You would be free to ask any question
about research work and treating doctor would be bound to answer them. If at any moment you
decide to withdraw from the study, you shall be free to do so, and in doing so you would not
experience any kind of loss in the form of penalty or loss of benefits, which you were otherwise
entitled to receive.
Amount of blood sample in quantity, in teaspoonful, to be taken should be mentioned:
Tea spoonful, for routine investigations

24
Costs and source of investigations, disposables, implants and drugs must be mentioned
The participation in the project will not add/ incur extraordinary expenditure on the patient,
investigations like Blood Investigations, OCT are available in the hospital and the cost will be
borne by railway administration.

Contact information:
DR TANVI JOSHI (DNB TRAINEE)
DEPARTMENT OF OPHTHALMOLOGY, NRCH
CONTACT : +91 8171207536

शोध में भाग लेने के ललए दी गयी जानकारी

सिय महोदय / महोदया,

आप प्रस्तालित अनुसंधान का लिस्सा बनने के ललए यिां आमंलित िैं:

फेम्टोसेकन्ड लेज़र अससस्टे ड कैटरे क्ट सर्जरी और कन्वेंशनल फेकोएमु ल्सिसफकेशन द्वारा ग्रेड III
मोसियास िंद के ऑपरे शन के ाद कॉसनजया के एिं डोथेसलअल सेल में होने वाले घटाव का िुलनात्मक
मूल्ािंकन

िस्तासवि अध्ययन उत्तर रे लवे केंद्रीय अस्पिाल, नई सदल्ली में आयोसर्ि सकया र्ाएगा। इस दस्तावेज़
में र्ानकारी यह िय करने में आपकी मदद करिी है सक आप को विजमान अध्ययन में भाग ले ना है या
नहीिं। आप इस अध्ययन में भिी होने की योर्ना नाने वाले 82 िसिभासगयोिं में से एक होिंगे।

अध्ययन का शीर्षक: फेम्टोसेकन्ड लेज़र अससस्टे ड कैटरे क्ट सर्जरी और कन्वेंशनल

फेकोएमुल्सिसफकेशन द्वारा ग्रेड III मोसियास िंद के ऑपरे शन के ाद कॉसनजया के एिं डोथेसलअल सेल में
होने वाले घटाव का िु लनात्मक मूल्ािंकन

उद्दे श्य और अध्ययन की लिलध:

1. स्पेक्युलर मतइक्रोस्कोप द्वारा एं डोथे ललयल सेल का घटाव (absolute number per mm
square) का सवश्लेषण कर एं डोथेललयल सेल में होने वाली कमी का ऑपरे शन के पूवज एविं
उपरािंि सदन 1, सदन 7, सदन 30 और सदन 60 पर िुलना करना

25
 2. कॉसनजया की केंद्रीय परि की मोटतई की वृल्सि (microns) का पेसकमे टरी द्वारा ऑपरे शन के पूवज
एविं उपरािं ि सदन 1, सदन 7, सदन 30 और सदन 60 पर िुलना करना

3. दे खने की क्षमिा ऑपरे शन के ाद स्नेलनचाटज द्वारा सदन 1 और सदन 7 को सनरीक्षण और

िुलना करनाI

प्रलिया

चूूँसक आपको मोसियास िंद का सनदान सकया गया है और उपचार करने वाले सचल्ससिक द्वारा सर्जरी
के सलए सिंचासलि सकया र्ाएगा , इससलए हम अध्ययन मैं आपको शासमल कर रहे हैं I अध्ययन में
अपनी भागीदारी के सलए सहमसि दर्ज करने के ाद आपको सिपी आविं टन सवसि के माध्यम से दो
में से एक ऑपरे सटव िसिया आविंसटि की र्ाएगी और सफर ऑपरे सटव िसिया का चयन करना
आपकी पसिंद नहीिं होगी ऑपरे शन से पूवज हम आपकी दृसि की र्ाूँ च, इिं टरा ऑक्युलर िेशर एविं
ल्सिट लैंप पररक्षण करें गे I आपकी IOL शल्सि की गणना की र्ाएगी और िी ऑपरे सटव दवाओिं
को समझाया र्ाएगा I मोसिया स िंद सर्जरी के ाद आपकी नेत्र परीक्षा सदन 1 और सदन 7 को
मानक िसिया के अनुसार की र्ाएगी I उपरोक्त सभी मतपदं डों को बेस लतइन पर ध्यतन लदयत
जतएगत और आपको ऑपरे शन उपरािं ि सदन 1, सदन 7, सदन 30 और सदन 60 को दृश्य सनररक्षण के
सलए ुलाया र्ाएगा

लिर्य भागी दारी की अपेलित अिलध: 2 महीने

शोध से लिर्य या दू सरों से अपेलित लाभ: र्ैसा सक अध्ययन अवसि के दौरान सकसी भी लाभ का
कोई आश्वासन नहीिं है, ि िंिन सनयसमि अस्पिाल के िोटोकॉल के अनुसार सकया र्ाएगा। लेसकन यह
अध्ययन ज्ञान िाप्त करने में मदद कर सकिा है र्ो भसवष्य में ऐसे रोसगयोिं के ेहिर ि िं िन में मदद
कर सकिा है।

अध्ययन से जुडे लिर्य का कोई भी जोखिम: कोई असिररि र्ोल्सखम नहीिं।

अलभलेिों की गोपनीयता का रि रिाि: आपकी भागीदारी से उत्पन्न डे टा से िाप्त आिं कडोिं का

सवश्लेषण सकया र्ाएगा और उन्हें केवल कानूनी व्यल्सियोिं र्ैसे ससिािंि अन्वेषक, अध्ययन कसमजयोिं और
नैसिक ससमसि और सनयामक असिकाररयोिं या सकसी व्यल्सि या एर्ेंसी द्वारा दे खा र्ा सकिा है यसद
कानून द्वारा आवश्यक हो। आपके व्यल्सिगि सववरण, इसिहास और अन्य सचसकिा र्ानकारी को
ससिािंि अन्वेषक द्वारा सनकट गोपनीयिा में रखा र्ाएगा। इस अध्ययन की र्ानकारी, यसद वैज्ञासनक
पसत्रकाओिं में िकासशि की गई है या नैदासनक ैठकोिं में िस्तुि की गई है, िो इससे आपकी पहचान
का पिा नहीिं चलेगा। अध्ययन के दौरान या ाद में आपकी पहचान पूरी िरह से गुमनाम रखी र्ाएगी।

अनुसंधान से संबंलधत चोट के ललए मुफ्त इलाज का प्रािधान: लागू नहीिं

ऐसी चोट के पररणामस्वरूप लिकलांगता या मृत्यु के ललए लिर्यों का मुआिजा: लतगू नहीं

आप को दिं ड या लाभ के नुकसान के स ना सकसी भी समय अनुसिंिान से पीिे हटने की स्वििंत्रिा होगी,
सर्सके सलए सवषय अन्यथा हकदार होिंगे

शालमल लकये गए लित्त : इस पररयोर्ना में भाग लेने से आप पर कोई व्यय/ खचज नहीिं होगा , क्योिंसक
वह एक रे लवे लाभाथी होने के नािे सभी खचों को रे लवे द्वारा कोवर सकया र्ाएगा

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अध्ययन से भाग लेने और लिथड्र ॉ करने के ललए स्वतंि
आपको शोि कायज में भाग लेने के सलए सूसचि सहमसि के सलए एक फॉमज पर हस्ताक्षर करने की
आवश्यकिा होगी र्ो सक उपचार करने वाले डॉक्टर द्वारा भी हस्ताक्षररि सकया र्ाएगा। आपको "मुझे
सूचना पत्र की एक िसि दी गई है" सलखने के ाद सूचना पत्र की एक िसिपर हस्ताक्षर करने की
आवश्यकिा होगी, सर्से डॉक्टर द्वारा रखा र्ाएगा और एक िसि आपको दी र्ाएगी।आप शोिकायज के
ारे में कोई भी सवाल पूिने के सलए स्वििंत्र होिंगे और उपचार करने वाला डॉक्टर उन्हें र्वा दे ने के
सलए ाध्य होगा।यसद सकसी भी समय आप अध्ययन से हटने का सनणजय लेिे हैं, िो आप ऐसा करने के
सलए स्वििंत्र होिंगे, और ऐसा करने पर आपको सकसी भी िरह के नु कसान या लाभ के नुकसान के रूप
में अनुभव नहीिं होगा, सर्से आप अन्यथा िाप्त करने के हकदार थे।

मािा में रक्त का नमूना, चम्मच में ललया जाना चालिए, का उल्लेि लकया जाना चालिए:
चायचम्मच, सनयसमि र्ािंच के सलए लागि और र्ािं च के स्रोि, सनपटान, ित्यारोपणऔर दवाओिं का
उल्लेख सकया र्ाना चासहए

अध्ययन में भती के ललए और आगे के प्रश्ों के ललए कृपया संपकष करें :
DR TANVI JOSHI (DNB TRAINEE)
DEPARTMENT OF OPHTHALMOLOGY, NRCH
CONTACT: +91 81712 07536

To, Date : Jan-29-2021

Institutional Ethical Committee
Northern Railway Central Hospital
New Delhi

Subject : Covering letter for submission of Protocol no: IEC -

NRCH/DNB/Protocol/2021/11

Respected sir/madam,

With due respect, I Dr. Tanvi Joshi, have developed my thesis protocol titled
“COMPARATIVE EVALUATION OF CORNEAL ENDOTHELIAL
CELL LOSS FOLLOWING FEMTOSECOND LASER ASSISTED
CATARCT SURGERY AND CONVENTIONAL
PHACOEMULSIFICATION IN GRADE THREE CATARACT” following
CONSORT statement guidelines, 2010 and all the points in checklist has
been addressed in the protocol. It will be registered with CTRI after
approval from ethics committee.

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Thanks and regards,

Dr Tanvi Joshi,
Post MBBS-DNB Resident
Dept of ophthalmology
NRCH, New Delhi

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