THESIS TITLE:

“Review study of minimal pneumo [gas] vitrectomy”

(For M.S. Ophthalmology)
Study Period: 2 Years (2023- 2025)

Dr. Sonali Choudhary

1 Year Resident Department of Ophthalmology
st

M & J Institute of Ophthalmology

B. J. Medical College Ahmedabad.
Contact No: 7976706152
Date of submission: 29/8/23

PROPOSAL

DR SONALI CHAUDHARY
1st YEAR RESIDENT
M & J INSTITUTE OF
OPHTHALMOLOGY
AHMEDABAD
(GOVERNMENT EYE HOSPITAL)
 Date:

To,
The Chairperson of ethics committee
Dissertation Review Board,
B. J. Medical College,
New Civil Hospital, Ahmedabad.

Subject: To grant ethical approval to conduct the study for dissertation entitled-
“Review study of minimal pneumo (gas) vitrectomy”

Respected Sir,
I, undersigned, Dr. SONALI CHOUDHARY, 1st year resident in Department of
Ophthalmology, M & J Western Regional Institute of Ophthalmology, affiliated with B.J. Medical
college, Ahmedabad wish to carry out the study entitled “REVIEW STUDY OF MINIMAL
PNEUMO (GAS) VITRECTOMY” as my dissertation under guidance of my PG teacher Dr.
JIGNESH GOSAI , Associate professor, in the Department of Ophthalmology at M & J Institute
of Ophthalmology.I am submitting herewith the study protocol, case record form (CRF) and
informed consent form for approval by the Ethical Committee. Kindly do the needful.

Guided by: Yours faithfully: Approved by:

Dr. Jignesh Gosai Dr Sonali Choudhary Dissertation
Associate Professor 1st Year Resident review board
M & J Institute of M & J Institute of M & J institute of
Ophthalmology Ophthalmology Ophthalmology
Civil Hospital Civil Hospital Civil hospital
Ahmedabad Ahmedabad Ahmedabad
1)STUDY TITLE-
“Review study of minimal pneumo (gas) vitrectomy”

2) INTRODUCTION - Retinal detachment is a condition in which the neurosensory retina is

separated from the retinal pigment epithelium. If untreated, permanent loss of vision may occur.
Types of retinal detachment include rhegmatogenous, exudative, tractional, combined tractional-
rhegmatogenous, and macular hole associated detachment. Rhegmatogenous retinal
detachment (RRD) is the most common of these.
RHEGMATOGENOUS RETINAL DETACHMENT
The word rhegmatogenous is derived from the Greek word rhegma, which means broken. The
pathogenesis of RRD involves vitreoretinal tractional forces that result in a full-thickness retinal break.
Liquefied vitreous gel then enters the subretinal space through the break, causing separation of the neu-
rosensory retina from the underlying retinal pigment epithelium. 1
RISK FACTORS:
Risk factors for RRD include
1)high myopia
2)trauma to the eye or head
3)RRD in the fellow eye
4) underlying hereditary vitreoretinopathy
5) previous intraocular surgeries and
6) previous viral retinitis

7) Other risk factors are intraocular procedures (especially vitreous manipulation), laser capsulotomy,
pseudophakia/aphakia,3 and retinal lesions such as lattice degeneration, snail track degeneration, snowflake
degeneration, vitreoretinal tufts, meridional folds, retinoschisis, and white lesions (with or without pressure).2

TREATMENT OPTIONS:
RRDs with superior breaks that threaten the macula require urgent vitreoretinal intervention. While
awaiting definitive management, patients should maintain a posture that prevents the subretinal fluid from
detaching the macula.
Definitive management of RRD includes barrier laser retinopexy in select situations, pneumatic retinopexy,
primary scleral buckle, primary pars plana vitrectomy (PPV) with intraocular tamponade or combined
scleral buckle and vitrectomy.

MINIMAL GAS VITRECTOMY:

Minimal gas vitrectomy utilizes a small gas bubble tamponade with no air fluid exchange.
PRINCIPLE- In a standard vitrectomy procedure retinal displacement post surgery can
occur in 40% to 50% patients, likely because of the buoyant force of the large gas bubble
leading to a stretch of the retina.
MGV can minimize retinal displacement by Avoiding drainage of subretinal fluid (SRF)
and air-fluid exchange with the intravitreal injection of small volume of gas (for example
0.6 ml of pure SF6 gas) and immediate initial face down positioning (STREAMROLLER
MANEUVER).

STREAMROLLER MANEUVER- After the gas is injected, the maneuver starts with immediate face down
positioning for 4 to 6 hours, followed by gradual elevation of the head until the head is upright. Then, the
patient will be positioned to allow the apex of the bubble to cover the retinal breaks.
PROCEDURE-

1)Carefully examine the eye with indirect ophthalmoscopy and scleral depression to identify areas of
pathology.

2)Anesthetize with peribulbar anesthesia.

3)Core vitrectomy is done.

4)Shave vitrectomy is done

5)Perform cryoretinopexy. (Alternatively, retinopexy can be performed using laser photocoagulation once
retinal apposition has been achieved after gas injection.)

6) Filter perfluoropropane gas (C3F8), sulfur hexafluoride gas (SF6), or air into a tuberculin
syringe on a 30-g needle.

7)Perform an anterior chamber paracentesis to remove 0.1 to 0.25 mL of aqueous humor.

8) Select a site perpendicular to the sclera, farthest away from the site of the underlying detachment, and
enter 3 to 4 mm from the limbus.

9) Withdraw the needle so that only its tip remains in the vitreous cavity, then carefully inject C3F8 (0.2-0.3
mL), SF6 (0.5-0.6 mL), or filtered air (0.8 mL), making sure that the needle tip is not in the suprachoroidal
space.

10)Reexamine with indirect ophthalmoscopy to confirm placement of gas bubble over the retinal break(s)
and perfusion of the central retinal artery (repeat paracentesis if arterial pulsations are absent).

11) Review head positioning and gas bubble precautions with the patient, with attention to later
expansion of the gas bubble.

3) OBJECTIVES-
a) To see if MGV is useful option with minimum surgical intervention in certain patients of
rhegmatogenous retinal dettachment.
b) To see the rate of primary anatomic reattachment following MGV.
c) To know the complications of MGV
d) To know the rate of improvement in BCVA after 3 months
e) To know the percentage of patients requiring re-surgery for re-detachment

4) ENDPOINT OF THE STUDY-

a) Number of patients with gas bubble in place and attached retina postoperatively
b) Change from baseline in BCVA

5) METHODOLOGY:

(A) Participant recruitment procedure: In this REVIEW STUDY being carried out at a tertiary
eye center in western India, all patients being diagnosed as Rhegmatogenous retinal
detachment and requiring surgery will be included after application of inclusion and exclusion
criteria and after taking informed consent of the participants.

(B) Inclusion Criteria for entry participants:

1. Patients giving Signed informed consent to study

2.Patients meeting PIVOT TRIAL CRITERIA
-Retinal break(s) located in the superior 2/3 of the fundus (from 8 to 4 o’clock)
-Single retinal breaks or multiple breaks within 1 clock hour (30 degrees) in detached retina
-No break in the inferior 4 clock hours
-breaks or lattice degeneration in attached retina at any location , even inferior aspect
3. Minimal media opacity
4. No proliferative vitreoretinopathy grade B or worse
5. Patient able to maintain positioning for 5-8 days after procedure
(C) Exclusion criteria:
1. Subjects meeting any of the following criteria are not eligible for inclusion in this study.

1. Physical inability to posture postoperatively

2. Inferior breaks in detached retina

3. Significant media opacity (vitreous hemorrhage, cataract)

 4. Proliferative vitreoretinopathy grade b or worse

5. Age less than 18 years

6. Mental incapacity

7. Preexisting occular diagnosis that would impact visual outcome

(D) Description of methodology

(1) Study Design: Review study

(2) Study type: Prospective and Interventional

(3) Study Area: M & J Western Regional Institute of Ophthalmology, affiliated with B.J.
Medical college, Ahmedabad

(4) Study Group: Patients of Rhegmatogenous retinal detachment requiring

management and meeting the inclusion criteria
(5) Sample size: 30

(6) Study Duration: 2 years

(7) Medical Devices/Drugs/Vaccines/Alternative Medicine/New

Technique/Diagnostic Kit to be used in the Study: Slit- Lamp Biomicroscope, non-
contact Tonometer, Indirect ophthalmoscope, Fundus camera, OCT (optical
coherence tomography) machine, 532 nm green laser, Vitrectomy machine, Cryo
machine, C3F8 gas or SF6 gas

(All above mentioned Medical Devices are either in Government Supply or Cost will be borne by
the Investigator)
(8) Materials and methods; -
There will be 2 period in study
a) Screening period
b) Treatment period

A). SCREENING; -
The following data shall be collected from patients as below at M & J Institute Of Ophthalmology
during 2 years.
1.Age, Gender of the patient
2.Symptoms at presentation
3.Medical history
4.vital signs
5.visual acuity- corrected and uncorrected, at presentation and at the end of follow up
6.slit lamp examination data
7. intraoccular pressure
8.Fundus photograph
9.optical coherence tomography
10.investigations
-Complete Blood Count
-Blood Sugar – Fasting blood sugar (FBS)
-Postprandial blood sugar (PP2BS)
-Glycosylated hemoglobin (HBA1c)
-Blood urea
-Urine analysis(routine)
-Serological Tests (HIV, HbSAg)
-Renal function test (RFT)
- Liver function test (LFT)
-Lipid profile

Patients will be explained regarding the procedure and a written consent will be taken.
Subject who consents will undergo screening assessments to evaluate their eligibility based on
inclusion and exclusion criteria.

B) TREATMENT PERIOD: -
Patients meeting inclusion criteria undergo surgery on an immediate basis. Patient is admitted
post-operatively for a day and explained streamroller manuever which is to be followed strictly
post surgery for atleast 1 week.
8)Data Analysis:

9) NAME OF PRINCIPAL INVESTIGATOR:

Dr. Sonali Choudhary
1st Year Resident,
M & J Institute of Ophthalmology,
Civil Hospital,
Ahmedabad

Guided by:

Dr. Jignesh Gosai

Associate Professor,
M & J Institute of Ophthalmology,
Civil Hospital,
Ahmedabad
REFERENCES

1 Kuhn F, Aylward B. Ophthalmic Res. 2014;51(1):15-31.

2 Schubert HD et al. Retinal detachment and predisposing lesions. Retina and Vitreous. San Francisco:
American Academy of Ophthalmology; 2016-2017.

3 Lincoff H, Gieser R. Arch Ophthalmol. 1971;85(5):565-569.

4 Dell'Omo R, Scupola A, Viggiano D, et al. Incidence and factors influencing retinal displacement in eyes
treated for rhegmatogenous retinal detachment with vitrectomy and gas or silicone oil. Invest Ophthalmol
Vis Sci 2017;58:BIO191–BIO199.

5 Brosh K, Francisconi CL, Qian J, et al. Retinal displacement following pneumatic retinopexy vs pars
plana vitrectomy for rhegmatogenous retinal detachment. JAMA Ophthalmol 2020;138:652–659.

6 Shiragami C, Fukuda K, Yamaji H, et al. A method to decrease the frequency of unintentional slippage
after vitrectomy for rhegmatogenous retinal detachment. Retina 2015;35:758–763.

7 Hillier RJ, Felfeli T, Berger AR, et al. The pneumatic retinopexy versus vitrectomy for the management
of primary rhegmatogenous retinal detachment outcomes randomized trial (PIVOT). Ophthalmology
2019;126:531–539.

8 Fajgenbaum M, Antonakis S, Williamson T, Laidlaw DA. Rate of post operative autofluorescent macular
shift with expanding gas bubble tamponade and no prone posture ambulatory care in patients with
macular involved retinal detachment. Ophthalmologica 2020;126:531–539.

9 Marafon SB, Juncal VR, Muni RH. Retinal shift with perfluorocarbon liquid without air-fluid exchange.
Ophthalmology 2020;127:598.
 PROFORMA
PRELIMINARY DATA:
• NAME:
• AGE:
• SEX:
• REG. NO.:

• PRIMARY VISIT :- • OCULAR SYMPTOMS:

• DURATION OF SYMPTOMS AT THE TIME OF PRESENTATION:

• PREVIOUS EYE DISEASES:

• PREVIOUS EYE SURGERY:

• H/O SYSTEMIC ILLNESS:

• GENERAL EXAMINATION

• OCULAR EXAMINATION

RIGHT EYE LEFT EYE

Unaided- Distant
BCVA
LID/LAC/ADNEXA
CONJ
C/S
AC
I/P
LENS
EOM
IOP

• SLIT-LAMP EXAMINATION
RIGHT EYE LEFT EYE
• FUNDUS
RIGHT EYE LEFT EYE

• OPTICAL COHERENCE TOMOGRAPHY

RIGHT EYE LEFT EYE

• INVESTIGATIONS DONE-

• DIAGNOSIS-

• INTERVENTION/S DONE:

• EXAMINATION ON FOLLOW UP-

VISUAL ACUITY

STUDY EYE
AIDED
UN-AIDED

• SLIT-LAMP EXAMINATION
STUDY EYE
• FUNDUS
STUDY EYE

• OPTICAL COHERENCE TOMOGRAPHY

STUDY EYE
 visual IOP SLE BCVA FUNDUS OCT
acuity
(unaided)

Baseline

Week 4

Week 8

Week 12

Week 16

Week 20

Week 24

Week 28

Week 32

Week 36

Week 40
Week 44

Week 48
 PARTICIPANT INFORMATION SHEET

I, Dr. Sonali Choudhary am doing my training for MS Ophthalmology at M and J Institute of

Ophthalmology, Ahmedadbad, I am conducting research on the above mentioned topic under
the guidance of Dr. Jignesh Y Gosai who is an Associate Professor of Ophthalmology in the
Department of Ophthalmology at M and J Institute of Ophthalmology, Ahmedadbad.
I am going to give you information and invite you to be a part of this research. You do not have
to decide today whether or not you will participate in the research. Before you decide you can
talk to anyone you feel comfortable with about the research.
There may be some words that you might not understand . Please ask me to stop as we go
through the information and I will take time to explain. If you have questions later, you can clarify
those with me.
1) What is the purpose of the study?
To present a novel technique, minimal gas vitrectomy, as a means of potentially minimizing
retinal displacement in selected cases of rhegmatogenous retinal detachment.
2) How do I participate in the study?

If you are willing to participate, you have to undergo consenting process. After which you will have to
undergo certain investigations and if deemed fit surgery will be performed as early as possible.
3) what is the cost of participating?
There is no cost for participating in the study.

4) Can I withdraw from the study later?

Yes, at any point during the course of study you are free to withdraw. Participation in the study
is voluntary and you are free to choose whether to continue further or withdraw without any pressure.
5) How long will I have to participate?
It is review study which need regular follow up every month for the period of one year.

6) How will my identity be protected?

All the information collected will be anonymous and no details specifying your name or identity will be
disclosed in any of the research data.

7) What are the benefits?

 You will be provided treatment during the study and your participation would be helpful in
determining efficiency and and drawbacks of the procedure. This will play important
contribution in further research.

8) What investigations will be done during the study?

The study includes various blood investigations to get baseline values, optical coherence
tomography, fundus photograph, BCVA to compare the results at the end of the study

9) Who is organizing and funding the study?

The study is organized by the Department of Ophthalmology at M & J Institute of

Ophthalmology, Ahmedabad. It is an unfunded study.

Thank you for taking time to consider this study. If you wish to take part in it, please sign the attached consent
form.
This information sheet is for you to keep.

The Consent Form will be read and explained to the participant before receiving the participant’s
consent, and it would be ensured that the participant has knowledge of the research project and
seemingly has understood it.
INFORMED CONSENT FORM:
CONSENT FORM

I enroll myself in the research project by Dr. Sonali Choudhary, resident in Ophthalmology department at M.
& J. Institute of Ophthalmology, B.J. Medical College, Ahmedabad. I am informed about the procedure of this
study. I know that my identity and the results will be kept confidential throughout the study and the result will
be used for research purpose only. I am not provided any remuneration for participation in the study, I also
know that I am free to withdraw the consent any time during study. I give consent on my own free will.

Signature of patient:

Name:

Address:

Date:

Investigator’s name and mobile number:

 सहमति पत्र

मैं खुद को एम एंड जे इंस्टीट्यूट ऑफ ऑप्थल्मोलॉजी, बीजे मेडिकल कॉलेज, अहमदाबाद में नेत्र
विज्ञान विभाग में रेसिडेंट डॉ. सोनाली चौधरी द्वारा शोध परियोजना में नामांकित करता हूं। मुझे इस
अध्ययन की प्रक्रिया के बारे में सूचित किया गया है। मुझे पता है कि मेरी पहचान और परिणाम पूरे
अध्ययन के दौरान गोपनीय रखे जाएंगे और परिणाम का उपयोग केवल शोध के उद्दे्य श्य के लिए किया
जाएगा। मुझे अध्ययन में भाग लेने के लिए कोई पारिश्र्रमिक प्रदान नहीं किया गया है, मैं यह भी
जानता हूँ कि मैं अध्ययन के दौरान किसी भी समय सहमति वापस लेने के लिए स्वतंत्र हूँ। मैं अपनी
मर्जी से सहमति देता हूं।

रोगी के हस्ताक्षर:

नाम:

पता:

तारीख:

जांचकर्ता का नाम और मोबाइल नंबर:

સંમતિ ફોર્મ
હું મારી નોંધણી ડૉ. સોનાલી ચૌધરી., રેસીડેન્ટ,એમ.& જે. ઇન્સ્ટિટ્ યૂટ ઑફ ઑપ્થેલ્મોલોજી, બી.જે. મેડિકલ કૉલેજ અમદાવાદમાં ઑપ્થેલ્મોલોજી વિભાગ, દ્વારા સંશોધન
પ્રોજેક્ટમાં કરું છું. મને આ અભ્યાસની પ્રક્રિયા વિશે જાણ કરવામાં આવી છે. હું જાણું છું કે મારી ઓળખ અને પરિણામો સમગ્ર અભ્યાસ દરમિયાન ગુપ્ત રાખવામાં
આવશે અને પરિણામનો ઉપયોગ માત્ર સંશોધન હે તુ માટે જ કરવામાં આવશે. મને અભ્યાસમાં ભાગ લેવા માટે કોઈ મહે નતાણું આપવામાં આવતું નથી, હું એ પણ જાણું છું કે
હું અભ્યાસ દરમિયાન કોઈપણ સમયે સંમતિ પાછી ખેંચી શકું છું. હું મારી સ્વતંત્ર ઇચ્છાથી સંમતિ આપું છું.

દર્દીની સહી:

નામ:

સરનામું:

તારીખ

તપાસકર્તાનું નામ અને મોબાઈલ નંબર: