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Diaton Tonometer Clinical Trials Guide PDF
Diaton Tonometer Clinical Trials Guide PDF
Diaton Tonometer use in Boston KPro Type 1. Clinical Study from University of Illinois
at Chicago: Agreement among Transpalpebral,Transcleral and Tactile Intraocular
Pressure Measurements in Eyes with Type 1 Boston Keratoprosthesis
Diaton tonometer use post LASIK: Diaton tonometer for intraocular pressure
measurements after laser in situ keratomileusis
Additional trials/articles can be found here:
http://www.tonometerdiaton.com/index.php?do=home.Comparison_clinical_trials_Diato
n_Tonometer_Goldmann_Tonopen_Applanation_Tonometers
Instructions Videos and step-by-step Easy to follow picture guides + Quick User Guide+
Training videos can be found here: https://tonometry.wordpress.com/2015/05/19/diaton-
tonometer-manual-quick-user-guide-how-to-use-diaton-tonometer-user-videos-helpfultips/
The following video would give you a great overview to see how quick and easy the test
really is: https://www.youtube.com/watch?v=Mfu2leF4UYw
Cacho I1, Sanchez-Naves J1, Batres L2, Pintor J3, Carracedo G4.
Purpose. To compare the intraocular pressure (IOP) before and after Laser In Situ
Keratomileusis (LASIK), measured by Diaton, Perkins, and noncontact air pulse
tonometers. Methods. Fifty-seven patients with a mean age of 34.88 were scheduled for
myopia LASIK treatment. Spherical equivalent refraction (SER), corneal curvature (K),
and central corneal thickness (CCT) and superior corneal thickness (SCT) were obtained
before and after LASIK surgery. IOP values before and after surgery were measured
using Diaton, Perkins, and noncontact air pulse tonometers.
Results. The IOP values before and after LASIK surgery using Perkins tonometer and air
tonometers were statistically significant (p < 0.05). However, no significant differences
were found (p > 0.05) for IOP values measured with Diaton tonometer. CCT decreases
significantly after surgery (p < 0.05) but no statistical differences were found in SCT (p =
0.08). Correlations between pre- and postsurgery were found for all tonometers used,
with p = 0.001 and r = 0.434 for the air pulse tonometer, p = 0.008 and r = 0.355 for
Perkins, and p < 0.001 and r = 0.637 for Diaton.
Conclusion. Transpalpebral tonometry may be useful for measuring postsurgery IOP
after myopic LASIK ablation because this technique is not influenced by the treatment.
PMID: 26167293 [PubMed] PMCID: PMC4475733
Diaton (p=0.04). The overall IOP mean SD was 17.2 6 mmHg for pneumatonometer
and 13.8 5 mmHg for Diaton tonometer.
Conclusions: The presence of KPro did not appear to interfere with IOP with Diaton
tonometer, and Diaton tonometer yielded IOP readings that were similar to those
obtained by palpation. Scleral pneumotonometry yielded values that were consistently
higher than tactile estimates and Diaton IOP. In addition to routine IOP estimates by
palpation, transcleral and transpalpebral IOP measurements can be considered to monitor
patients with KPro.
The interclass correlation coefficient was satisfactory for the three measures with the
transpalpebral tonometer (0.88- CI: 0.80 to 0.92), but not satisfactory among the three
tonometers (0.60 CI: 0.35 to 0.76).
The regression analysis of the differences shows a trend of the discordance on the
extreme values of the Tonopen and the transpalpebral tonometer comparing to the
Goldmann tonometer. For the lowest intraocular pressures the transpalpebral tonometer
trends to measure the pressure higher and, for the highest pressures, the transpalpebral
tonometer trends to measure lower, which is the same for Tonopen, independently of the
group, however the lower intraocular pressure were of the keratoconus group.
Conclusion:
The measures of the transpalpebral tonometer show satisfactory reproducibility and their
concordance with the Goldmann, mainly in the patients with keratoconus on which the
pressure values were higher than the Goldmann, may trend to measure a value closer to
the real intraocular pressure, as the Goldmann tonometer underestimates the intraocular
pressure on patients with keratoconus.
Tonometric Values of Intraocular Pressure, Using the Goldmann Tonometer, Tonopen
and Diaton Transpalpebral Tonometer in Keratoconus
mmHg). The increase of IOP was observed during the intake of the nitrates (mean initial
IOP 18,81,2 mmHg, mean IOP after 7-14 days 23,81,3 mmHg). According to the
results of the acute pharmacological testing the IOP increase was observed 40 min after
the intake of one dose (1,25 mg) of Isosorbide dinitrate and remained increased up to
1,5 hours on patients with POAG (mean initial IOP 22,71,8 mmHg, IOP after 40 min
26,11,9 mmHg, IOP after 90 min 25,81,9 mmHg).
Conclusions:
Portable, ergonomic ophthalmo-tonometer diaton suits perfectly in general medical
practice for IOP monitoring to make anti-hypertensive drugs treatment safe.
Before and after the surgery all patients were subject to the complete refractive examination,
including keratotopography and wavefront-aberrometry (AMO, USA). In a number of patients
for cornea state morphologic evaluation we conducted US-biomicroscopy of the corneal optical
zone before and in two months after laser correction (Picture 1).
Before and after surgery we trice measured pachymetry corneal thickness in central (4 points)
zone - central corneal thickness (CCT) in each patient. We realized the study using two devices:
US-pachymeter UP 1000 by NIDEK (Japan) and -scan-pachymeter P55 by Paradigm (USA).
IOP was measured with Goldmann applanation tonometer (Rodenstok, Germany),
pneumotonometer (NIDEK, Japan) and transpalpebral scleral diaton tonometer (RSIME, Russia,
picture 2) using traditional methodology (picture 3), all ophthalmotone measurements were
realized the patients being in the sitting position with time interval being 2-3 minutes between
two investigators.
The surgeries were carried out using excimer laser VISX Star S4 IR (AMO, USA),
microkeratome LSK Evolution II (Moria, France) and epikeratome Centurion SES (Norwood,
Australia)
Statistical treatment of the received results was realized using common methods of medical
mathematical statistics. Statistic calculations were carried out using "Analysis Tools Pack".
Determination of differences reliability between the groups being compared in the presence of
normal distribution in sampling of one-type factors was realized using two-sample t-tests.
Correlation analysis by Pearson allowed detecting the character of correlations between
showings. Correlation with <0,05 was considered to be reliable.
Results and discussion
In 93,6% cases visual acuity without correction after surgery was 0,6 - 1,0 (Table 1) in the early
postoperative period.
Results of the study are shown in Tables 2 and 3.
While analyzing morphometric parameters in the group of patients which were not the subject to
photorefractive surgeries the mean PCT value was 554,532,4 m, and the mean value of
applanational IOP - 16,12,6 mm Hg, the fluctuation being from 10 to 21 mm Hg; mean
ophthalmotone level evaluated with diaton tonometer - 14,72,5 mmHg, the fluctuation being
from 9 to 20 mmHg. At that correlation between values of the applanation tonometer and
transpalpebral scleral diaton tonometer was highly reliable (r = 0,73, 0,005). To define the
advantages of scleral tonometry in comparison with the traditional keratoapplanational method
we made calculations of real ophthalmotone in the patients of this group taking into account
pachymetry (PCT), ophthalmometry and applanation tonometry data. Mean value of the real IOP
after applanation value converting was 15,42,4 mmHg. Pearson correlation coefficient between
real IOP (modified result, received with applanation tonometry) and the value, determined with
diaton tonometer was 0,89, <0,005, which shows high reliability of transpalpebral scleral
tonometry.
In the groups of patients, underwent photorefractive vision correction, mean PCT was
499,850,9 m (fluctuations from 407 to 513 m), mean applanation value of IOP - 12,42,91
mmHg (fluctuations from 7 to 20 mm Hg), modified taking into account keratometry IOP rates 13,93,0 mm Hg, mean diaton-tonometry result - 15,12,75 mm Hg. At that we notice
approximation of diaton-tonometry figures to the modified applanation IOP value taking into
consideration keratometric rates - increase of correlation coefficient from 0,51 to 0,81 (table 4).
Correlation analysis of PCT and IOP results in the group of patients, examined both in
preoperational period and after photorefractive vision correction showed reliability of this
correlation, p<0,005, reduction of IOP for 1 mm Hg is registered PCT being decreased for 29,7
m. At that difference between pre- and postoperational IOP during applanation tonometry was
3,5 mm Hg, and during diaton-tonometry - 1,8 mm Hg, that is statistically dissimilar (t>2,
p<0,005), which shows significant advantage of ophthalmotone evaluation if we omit cornea.
Conclusion. Thus, cornea thickness is the important factor of IOP evaluation and monitoring and
requires the necessity of including corneal pachymetry in the program of examination the
patients with suspicion of glaucoma and hypertension, especially after various keratorefractive
surgeries while using the traditional corneal methods of ophthalmotonometry. At the same time
clinical application of transpalpebral scleral diaton tonometer makes it possible to evaluate IOP
using only one device, the procedure being efficient, economical, simple in performance and
requiring no additional instrumental examination.
Literature
Nesterov A.P. Transpalpebral tonometer for intraocular pressure measuring.// Ophthalmology
Bulletin - 2003. - Vol. 119. - 1. - P. 3 - 5.
Blaker JW, Hersh PS. Theoretical and clinical effect of preoperative corneal curvature on
excimer laser photorefractive keratectomy for myopia.//Refract. Corneal Surg. - 1994;-Vol.10:P.
571-574.
Buratto L, Ferrari M, Genisi C. Myopic keratomileuesis with the excimer laser: one-year followup.//Refract. Corneal Surg. - 1993;-Vol.9:P.12-19.
Cennamo G, Rosa N, La Rana A, et al. Non-contact tonometry in patients that underwent
photorefractive keratectomy.//Ophthalmologica.- 1997;-Vol. 211:P.341-343
Duch S, Serra A, Castanera J. Tonometriy after laser in Situ keratomileusis treatment. //J
Glaucoma. - 2001. - Vol.10. - P. 261 - 265.
Emara B.et al. Correlation of intraocular pressure and corneal thickness in normal myopic eyes
and after laser in situ keratomileusis.//J. Cataract. Refract. Surg. - 1998;-Vol.24(10):P. 13201325
Mardelli PG, Piebenga LW, Whitacre MM. The effect of excimer laser photorefractive
keratectomy on intraocular pressure measurements using the Goldmann applanation tonometer
//Ophthalmol. - 1997. - Vol.104. - P. 945-948.
Pandav SS, Ashok Sharma, Amit Gupta. Reliability of Proton and Goldmann applanation
tonometers in normal and postkeratoplasty eyes. //Ophthalmol. - 2002. - Vol. 109. - P. 979-984.
Simon G, Small RH, Ren Q, et al. Effect of corneal hydration on Goldmann applanation
tonometry and corneal topography.//Refract. Corneal Surg.- 1993;-Vol. 9:P.110-117
Vakili R, Choudhri SA, Tauber S, Shields MB. Effect of mild to moderate myopic correction by
laser-assisted in situ keratomileusis on intraocular pressure measurements with goldmann
applanation tonometer, tono-pen, and pneumatonometer. //J Glaucoma. - 2002. - Vol.11. - N6. P. 493-496.
Whitacre MM, Stein R. Sources of error with use of Goldmann-type tonometers. //Surv
Ophthalmol. - 1993. - Vol. 38. - P.1 - 30.
Wu X, Liu S, Huang P, Wang P. Analysis of intraocular pressure after myopic photorefractive
keratectomy. //Chung Hua Yen Ko Tsa Chih. - 2002. - Vol.38. - N10. - P.603-605.
Zadok D, Raifkup F, Landao D. Intraocular pressure after LASIK for hyperopia. //Ophthalmol. 2002. - Vol. 109. - P.1659-1661.
Picture 1 Topographic ultrasonic biomicroscopy of the cornea in optical zone of normal myopia
eye (), after PRK (B) and after LASIK (C)
Cornea, as the
basic optical lens of the eye, is the main element to be influenced during various, and first of all
laser, surgeries with refractive, reconstructive, optical and other purposes. Picture 2
Transpalpebral scleral diaton tonometer
Methods
Retrospective chart review of consecutive IOP measurements performed on 64 eyes of 32
patients age 34-91 years with both the Diaton tonometer and Goldmann applanation.
Results between groups were examined using analysis of variance (ANOVA) where
appropriate.
Results
Mean IOP was 15.09 +/-4.31 mm Hg in the Goldmann group and 15.70 +/-4.33 mm Hg
in the Diaton group (p=0.43).
Mean IOP variation between groups was 1.74 +/-1.42 mm Hg (range 0-8). 83% of all
measurements were within 2 mm Hg of each other.
Conclusions
The transpalpebral method of measuring IOP with the Diaton tonometer correlates well
with Goldmann applanation. Diaton applanation may be a clinically useful device for
measuring IOP in routine eye exams.
http://tonometerdiaton.com/index.php?do=home.Comparison_Study_Diaton_Tonometer_
Goldmann
We looked at 74 eyes of 38 consecutive patients who received both Tonopen and Diaton
tonometry
TonoPen measurements were taken in the sitting position following topical anesthesia
with proparicaine.
Diaton measurements were performed in the sitting position with the patient gazing at a
45o angle, placing the eyelid margin at the superior limbus. If necessary, gentle traction
was placed on the brow to align the lid with the limbus. The device was activated when
the signaling mechanism indicated the device was vertical.
Results
Age range 3-91 years of age (mean 47.5 years).
The average IOP with the Diaton was 16.24 (+/-5.11 mm Hg; range = 7-32 mmHg).
The average IOP with the TonoPen was 16.37 (+/-4.90 mm Hg; range = 8-33 mmHg).
The mean variation between the two modalities was 1.59 mmHg (+/-1.31 mm Hg; range
= 0-6 mmHg).
Eighty-one percent of all measurements were within 2 mmHg of each other (Table 1).
There was no statistically significant difference in mean IOP values obtained with the
two devices (p=0.87). Table
Conclusions
The Diaton tonometer pressure measurements correlated well with TonoPen
measurements in this retrospective review.
We did not find problems performing the exam in children, and many were reassured by
the fact that no drops were needed.
There may be a notable benefit in patients after refractive surgery or with corneal
pathology since the Diaton does not applanate the cornea.
The Diaton tonometer appears to be a clinically useful device in the IOP measurement
of both children and adults.
References
Li J, Herndon LW, Asrani SG, Stinnett S, Allingham RR. Clinical comparison of the
Proview eye pressure monitor with the goldmann applanation tonometer and the
TonoPen. Arch Opthalmol 2004;122:1117-21.
Eisenberg DL, Sherman BG, McKeown CA, Schuman JS. Tonometry in adults and
children: a manometric evaluation of pneumotonometry, applanation, and TonoPen in
vitro and in vivo. Ophthalmology 1998;105:1173-81.
Diaton: digital portable tonometer of intraocular pressure through the eyelid. Operation
Manual. Ryazan State Instrument Making Enterprise. Ryazan, Russia.
Garcia Resua C, Giraldez Fernandez MJ, Cervino Exposito A, Gonzalez Perez J, YebraPimentel E. Clinical evaluation of the new TGDc-01 "PRA" palpebral tonometer:
comparison with contact and non-contact tonometry. Optom Vis Sci 2005;82:143-50.
Troost A, Yun SH, Specht K, Krummenauer F, Schwenn. Transpalpebral tonometry:
reliability and comparison with Goldmann applanation tonometry and palpation in
healthy volunteers. Br J Ophthalmol 2005;89:280-3.
Losch A, Scheuerle A, Rupp V, Auffarth G, Becker M. Transpalpebral measurement of
intraocular pressure using the TGDc-01 tonometer versus standard Goldmann
applanation tonometry. Graefes Arch Clin Exp Opthhalmol. 2005;243:313-6.
Test report and a comparison of the pressure measurements of the digital portable
tonometer DIATON for the measurement of the intraocular pressure through the
eyelid
The eyeball is a reservoir of the spherical form, filled with fluid, incompressible contents. IOP is
caused by the influence of the elastic forces, arising in eye coverings while they are being
stretching.
IOP level is determined by watery moisture (WM) circulation in an eye and by pressure in
episclera veins [3]:
PO=F/C+Pv,
where PO IOP; F WM minute volume; C coefficient of easiness of WM flow-out from an
eye, Pv pressure in episclera veins.
IOP increases while moving from vertical to horizontal position and especially in Trendelenburg
position and while squeezing the necks veins because of the pressure increasing in episclera
veins (Pv) [4].
IOP is a dynamic, continuously changing value. They distinguish its system, rhythmic fluctuations
around relatively constant level and momentary changes of casual character. IOP fluctuations
around the level depend on changes in bloodfilling of intraocular vessels and on outer pressure
on the eyeball.
There are 3 types of rhythmic IOP fluctuations around the level [3]:
1.eye pulse (from 0,5 to 2,5 mm Hg),
2.respiratory waves ( from 0 to 1 mm Hg),
3.Hering-Traube waves (from 0 to 2,5 mm Hg).
The successive measurings of IOP in the same eye with a tonometer vary
from each other mainly due to the ophthalmotone rhythmic fluctuations.
Winking, pressing of the eye with orbicular muscle or external muscles of the eyeball
momentary increase IOP, provide eye massage and decrease venous congestion. At the same
time changes of orbicular and transpalpebral muscles tone during tonometry are often the
cause of error while measuring IOP level.
Statistically normal IOP varies from 9 to 21 mm Hg (on average 15-16 mm Hg). It has daily and
seasonal fluctuations. The IOP distribution in the normal population is asymmetrical (splayed to
the right). In middle age the distribution asymmetry increased. More than 3% of healthy persons
have IOP above 21 mm Hg [4]. The ophthalmotone measuring accuracy in the area of the normal
and reasonably increased (up to 30 mm Hg) IOP is especially important for a practical doctor.
Intraocular pressure regulation
Each eye is adjusted to a certain IOP level (balance pressure) which is supported by passive and
active mechanisms. IOP being increased pressure of moisture flow-out and filtration from an eye
increased, WM production being decreased its flow-out decreased and the balance pressure
restores.
Active mechanisms of IOP regulation have been not enough studied. Collaboration of
hypothalamus, adrenal glands, vegetative nervous system and local autoregulatory mechanisms
is possible.
Opthalmotonometry
The IOP measuring is based on the eyeball deformation under the influence of an outer effect.
At that the values of deformation (S), the force (W) influencing the eye and IOP (Pt) as a first
approximation are connected with each other with the following dependence [5]: Pt = f(W/ S).
All tonometers fall into devices: 1) with constant and variable pressure force on the eye, 2) with
constant and variable value of eye deformation, 3) corneal, scleral and transpalpebral, (4)
applanation, impression and ballistic.
Ophthalmotonometers used in the Russian Federation
1.Maklakov tonometer and Filatov-Kalve elastotonometer.
2.Goldmann applanation tonometer (reference)
Fig.1
The peculiarities of the new tonometer are that IOP measuring is realized through the eyelid
that excludes contact with conjuctiva and cornea and does not require anesthetics application.
At that the mechanical influence on the eye is realized through the eyelid on sclera. The
tonometeres position while measuring IOP is shown on fig.2.
Fig.2
The measuring principal of the new tonometer is based on processing the rod movement
resulting from its free fall and interaction with the elastic surface of the eye to be measured.
The main problem was how to exclude the influence of an eyelid individual peculiarities on the
tonometry results. This was solved by pressing the eyelid on the area with the diameter of 1,5
mm to such extent that the pressed area of the lead acts like a rigid transfer link while the rod
interacts with the eye at the same time excluding the painful sensation. This method of
compensating the eyelid influence led to the choose of dynamic (ballistic) way of dosated
mechanical influence on the eye for evaluating its elastic peculiarities.
To determine the position in the process of its free fall from the constant height and the
interaction with eye through the eyelid the device has position sensor. Value of the points of the
rod movement function in time is remembered by the built-in processor. In diagram form the
function of the rod movement in time is shown in fig.3.
area - S are constants So to evaluate P it is enough to measure the rod movement acceleration
(a) in point B.
Errors of IOP measuring
In clinical practice it is customary to evaluate errors of IOP measuring with the new tonometers
in comparison with the results received in the same eyes with Goldman tonometer (Reference
tonometer) and taking into consideration scatter of data received during repeated measurings
with the same tonometer [8].
Numerous studies carried out in hundreds of patients during several years show high reliability
of IOP measurings with diaton tonometer. Scatter of results received using the new tonometer
and Goldman tonometer had no systematic character and did not exceed 4 mm Hg. In repeated
IOP measurings in healthy eyes the displays fluctuations were in the range 2-4 mm Hg [1].
According to the literature data the scatter of results while carrying out the repeated
measurings using Goldman tonometer is 2-3 mm Hg in healthy eyes [10]. While checking various
samples of Goldman tonometers produced in lots it is found the systematic difference of the
displays of 2-3 mm Hg depending on the variant of each devices double prism and spring
calibration. Eye refraction, astigmatism, corneas crookedness and thickness, width of the
moisture ring around the flattening area, hyper- or hypofluorescence of the ring [6, 7, 9]. As it
was mentioned above, the error of IOP level measuring depends on the character and value of
ophthalmotone rhythmic and casual fluctuations as well as on the tonometrists skill.
The experience of operating diaton and Goldman tonometers shows that their displays have
good correlation.
Diaton tonometer has accuracy enough for clinical purposes, requires no anesthetics and
sterilization. Besides, they are safe (can not damage the cornea), comfortable for the patients
and easy in use. They can be used not only in ophthalmology studies but at home as well.
LITERATURE
1. .., ..//..-2001-2.-.55-56
2. ..//..-1884.-.22-.1092-1095
3. .., .., .. :
.-.,1974
4. .. .-.,1995
5.Goldmann H., Schmidt T.//Opthalmologica.-1957-Bd 136.-S.221-231.
6.Mark H.H.//Am.J.Ophthalmol.-1973.-Vol.76-P.223-227
7..//Ibid.-1960.-Vol.49.-P.1149
8.Moses R.A., Liu C.H.// Ibid.-1968.-Vol.66.-P.89-94
9.Motolko M.A.//Can/J/Ophthalmol.-1982.-Vol.17.-P.93-97.
10.Phelps C.D.,Phelps G.K.//Graefes.Arch.Clin.Exp.Ophthalmol.-1976.-Vol.198.-P.39-44
11.Schottenstein M.H.//The Glaucomes/Eds R.Ritch et al.-St.Louis, 1996.-Vol.1.-P.407-428.
12.Whitacre M.M., Stein R.A., Hassanein K.//Am.J.Ophthalmol.-1993.-Vol.115.-P.592-597.
Dear Sir/Madam,
Attached please find pictures of recent activity at Mother Theresas orphanage and old age home
were 200 needy people underwent eye exam and glaucoma screening. Fifteen people were
glaucoma suspects and 3 with advanced glaucoma.
This screening would have not been possible without your generous donation of Diaton
tonometer, a wonderful marvel of technology, that made this massive screening for glaucoma an
easy one and with perfect accuracy.
Old age people normally have dry eyes,poor tear film quality, where there is a risk of corneal
damage with schiotz tonometry and applanation tonometry needs use of lots of fluoroscein dye
because it dries up fast. With Diaton tonometer this was not a problem ! Diaton tonometer is the
best and only device suitable for use with aged patients and those with dry eyes.
Thank you Diaton for wonderful device thats going to help save sights of thousands of people.
God bless.
Please go through attached pictures.
Kind regards,Dr. Shabbir Kapasi Ph.D(MA)
ELITE OPTICIANS
Jamhuri/India street, Opp. Ministry of Science & Technology Bldg., P.O. Box
1737, Dar Es Salaam, Tanzania.