(290 days)
Not Found
No
The device description details a physical measurement principle based on vibration and mechanical properties, with no mention of AI/ML algorithms for data processing or interpretation. The performance studies focus on comparing the device's measurements to a predicate device and a reference standard, not on validating an AI/ML model.
No
The device is indicated for the measurement of intraocular pressure, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that "The Tonometer Easyton is indicated for the measurement of intraocular pressure in human eyes." Measuring intraocular pressure is a diagnostic function, as it provides information used to identify or monitor a medical condition (e.g., glaucoma).
No
The device description clearly details a physical vibrator, rod, and electromagnetic components, indicating it is a hardware device with associated software for calculation and display.
Based on the provided information, the Tonometer Easyton is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Tonometer Easyton's Function: The Tonometer Easyton directly measures intraocular pressure (IOP) in the human eye by applying a physical force to the eyelid. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states "measurement of intraocular pressure in human eyes," which is a direct measurement on the body, not an analysis of a sample taken from the body.
Therefore, the Tonometer Easyton falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Tonometer Easyton is indicated for the measurement of intraocular pressure in human eyes.
Product codes (comma separated list FDA assigned to the subject device)
HKX
Device Description
The principle of EASYTON measurement is based on simultaneous use of the two types of measuring actions – static and dynamic. Both actions are carried out by the vibrator's rod on the eyelid. Static action is carried out during the time of measurement and determined by the weight of the vibrator. Dynamic exposure represents itself during the vibrating action with frequency: about 150 HZ and amplitude: the millimeter hundredth parts and tactile is felt as soft vibration. Vibrator's rod is elastically movable in its axial direction and is set in oscillatory motion by electromagnetic way. While carrying out the measurement, the rod is put up on the eyelid, sagging (pressing the eyelid down with its weight about 10g and is fixed on sclera or an eye cornea forming elastic system of eye-vibrator with total mechanical rigidity. This system is disturbed from the equilibrium state by the rod's short term electromagnetic removal. In a system within tan equilibrium state restoration there are arising free damped vibration. Functional connection between elastic system rigidity and the period of is own vibration is known. This period is measured by the tonometer and is used for IOP calculation being shown on the display. When the EASYTON rod is placed on the eyelid and slightly pressed on the device, the rod slightly plunges into the device, and the generation of a measuring vibration effect begins. The vibration frequency of the "rod-eye" depends on the IOP. The higher the IOP, the greater the vibration frequency. The device registers the vibration frequency, recalculates it into the IOP value and displays it on its indicator. EASYTON measures only the intraocular pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eyes (measured through the eyelid in the scleral area corresponding to corona ciliaris in the meridian of 12 hours)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Three comparative studies were carried out for measurements of IOP using the Easyton and Goldmann Applanation Tonometers. All three studies were conducted in accordance with the requirements of ANSI Z80.10-2014.
-
"Low stiffness eyelids study": 156 patients (eyes) distributed in 3 IOP ranges (7 to 16: 46 eyes [≤3D Cyl], 10 eyes [>3D Cyl]; >16 to 3D Cyl]; >23: 40 eyes [≤3D Cyl], 10 eyes [>3D Cyl]). Conducted in the Glaucoma Community of Russia, IPO (Moscow, Russia).
-
"Epicanthus study": 150 patients (eyes) distributed in 3 IOP ranges (7 to 16: 40 eyes [≤3D Cyl], 10 eyes [>3D Cyl]; >16 to 3D Cyl]; ≥23: 40 eyes [≤3D Cyl], 10 eyes [>3D Cyl]). Conducted in Regional Medical Center (Karaganda, Kazakhstan) and TENSV Clinic, LLP (Karaganda, Kazakhstan).
-
"Rigid stiffness eyelids study": 78 patients (155 eyes) distributed in 3 IOP ranges (7 to 16: 53 eyes [≤3D Cyl]; >16 to 3D Cyl): Bias +0.83 mmHg, Slope 1.035, +/- 1.96 SD 3.13 mmHg
-
"Epicanthus study" (Asian population, fatty eyelids):
- Sample Size: 150 patients (eyes)
- Key Results:
- Main Group (≤3D Cyl): Bias +0.32 mmHg, Slope 1.02, +/- 1.96 SD 2.59 mmHg
- Astigmatic Group (>3D Cyl): Bias +0.77 mmHg, Slope 0.948, +/- 1.96 SD 2.10 mmHg
-
"Rigid stiffness eyelids study" (Indian population, stiff eyelids):
- Sample Size: 78 patients (155 eyes)
- Key Results:
- Main Group (≤3D Cyl): Bias -0.88 mmHg, Slope 0.923, +/- 1.96 SD 4.01 mmHg
Overall, the results from all three studies showed that for all types of tested eyelids, requirements of Z80.10-2014 are met, because not more than 5% of the paired differences between the reference tonometer reading and the test tonometer reading for each pressure range are greater than the tolerance for that range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Diaton, K060780
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2019
Company Elamed Mikhail Kuzin Certification Engineer Yelatma instrument-making enterprise JSC 391351, 25 Janina St. Yelatma, RU Ryazan region
Re: K190382
Trade/Device Name: Intraocular Pressure Tonometer EASYTON Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKX Dated: October 29, 2019 Received: November 4, 2019
Dear Mikhail Kuzin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general control's provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidanceregulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-devicesafety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally. you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190382
Device Name Easyton
Indications for Use (Describe)
The Tonometer Easyton is indicated for the measurement of intraocular pressure in human eyes.
Type of Use (Select one or both, as applicable)
| Residential Use (Per CAI Statutes, Please see CAI Law Center at CAIonline.org) |
|---|
| Commercial Use (Per CAI Statutes, Please see CAI Law Center at CAIonline.org) |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for ELAMED. The logo is green and features a stylized tree symbol to the left of the company name. The company name is in all caps and is also green. The logo is set against a white background with horizontal green lines.
All for your health. Health for you.
Yelatma Instrument Making Enterprise, JSC
25 Yanin st., Yelatma, Ryazan region, 391351, Russia. Tel./fax: +007 49131 / 2-04-57, 2-21-09, 4-38-29
510(k) Summary Complying with 21 CFR 807.9
I. SUBMITTER
Company Elamed Yelatma instrument-making enterprise, JSC 391351, 25 Janina st., Yelatma, Ryazan region, Russia
Phone: +7 (4912) 513-565 Fax: +7 (49131) 204-57
Contact Persons: Mr. Mikhail Kuzin Certification Engineer Company "ELAMED" Phone:: +74912776059 x 2256 or +79537428930 Address: Russia,Ryazan,Vysokovoltnaya street 48 E-mail: kuzin_mn@elamed.com
Alternate Only: Mr. Borovkov Oleg Registration Team leader Company "ELAMED" E-mail: borovkov@elamed.com Phone: +74912776059 x 2254 Address: Russia,Ryazan,Vysokovoltnaya street 48
II. DEVICE
Name of Device: Intraocular Pressure Tonometer EASYTON Common or Usual Name: tonometer, ac-powered Regulation: 886.1930 Regulatory Class: II Product Code: HKX
III. PREDICATE DEVICE
Diaton, K060780 This predicate has not been subject to a design-related recall.
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IV. DEVICE DESCRIPTION
Device Description
A. Principles of Operation
Measurement Method
The principle of EASYTON measurement is based on simultaneous use of the two types of measuring actions – static and dynamic. Both actions are carried out by the vibrator's rod on the eyelid.
Static action is carried out during the time of measurement and determined by the weight of the vibrator.
Dynamic exposure represents itself during the vibrating action with frequency: about 150 HZ and amplitude: the millimeter hundredth parts and tactile is felt as soft vibration. Vibrator's rod is elastically movable in its axial direction and is set in oscillatory motion by electromagnetic way. While carrying out the measurement, the rod is put up on the eyelid, sagging (pressing the eyelid down with its weight about 10g and is fixed on sclera or an eye cornea forming elastic system of eye-vibrator with total mechanical rigidity. This system is disturbed from the equilibrium state by the rod's short term electromagnetic removal. In a system within tan equilibrium state restoration there are arising free damped vibration.
Functional connection between elastic system rigidity and the period of is own vibration is known. This period is measured by the tonometer and is used for IOP calculation being shown on the display.
| Image: [Schematic representation of the tonometer rod movements.]
Fig. 1
Schematic representation of the tonometer
rod movements. | When the EASYTON rod is placed on the
eyelid and slightly pressed on the device,
the rod slightly plunges into the device, and
the generation of a measuring vibration
effect begins.
This is schematically shown in Figure 1.
The vibration frequency of the "rod-eye"
depends on the IOP.
The higher the IOP, the greater the vibration
frequency.
The device registers the vibration frequency,
recalculates it into the IOP value and
displays it on its indicator. |
| -------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
EASYTON measures only the intraocular pressure. Operating principle of the tonometer.
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Technical Specifications
| Specification | Value |
|---|---|
| Measuring range of IOP, mmHg | 7 to 50 |
| Limits of permissible absolute error of measurement: | |
| From 7 to 23 mm Hg | +/- 2 |
| More than 23 mm Hg | +/- 5 |
| Measurement time (sec) | 2 |
| Repeatability (coefficient of variation), % | ≤8,1 |
| applanation area, contact area, or area of corneal deformation | None |
| type of pressure transducer (e.g., optical detector, strain | |
| gauge) and specifications | Inductive |
| Power supply: | |
| Number of elements x voltage, V | 2 x 1,5 |
| Type of battery | AAA |
| Power supply voltage, V | 2 - 3,3 |
| Current consumption in measurement mode, mA, not more | 100 |
| Display | LCD |
| Data output | Display |
| data storage capability (e.g., measurement results, patient | |
| information) | Store of last measurement |
| result until power off | |
| interface with other equipment (e.g., printer, computer | |
| network) | None |
| dimensions (L x H x W) mm, not more | 173 x 27 x 21 |
| weight (g) | 88 |
| Operating temperature range, C (need F) | +10 to +35 |
| Relative air humidity, %, not more | 80 |
| Atmospheric pressure, kPa | 84 to 106.7 |
V. INDICATIONS FOR USE
The Tonometer Easyton is indicated for the measurement of intraocular pressure in human eyes.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Item | Intraocular
Pressure
Tonometer
EASYTON | DIATON | Substantially
Equivalent or Different |
|---------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------|
| Indications for Use | The Tonometer
Easyton is indicated
for the measurement
of intraocular | The Diaton Tonometer
is intended to measure
intraocular pressure
(IOP). The device is | Substantially Equivalent |
6
| | pressure in human
eyes. | intended for use as an
aid in the diagnosis of
glaucoma and for
monitoring IOP. | |
|--------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------|
| Classification | product code HKY
(regulation number
886.1930) | product code HKY
(regulation number
886.1930) | Substantially Equivalent |
| Materials | Biocompatible
patient contacting
materials | Biocompatible patient
contacting materials | Substantially Equivalent |
| Sterilization method | not sterilized | not sterilized | Substantially Equivalent |
| Technological
Characteristics: | | | |
| Measurement on base | Goldman | Maklakov | Different |
| Measurement range (Hg) | from 7 to 50 | from 5 to 60 | Substantially Equivalent |
| Time of single measurement
(sec) | 2 | 3 | Substantially Equivalent |
| Power supply type and
voltage | 1,5 V AAA x2 | 1,5 V AAA x2 | Substantially Equivalent |
| Size/dimensions (mm) | 173 x 27 x 21 | 174 x 26 x 20 | Substantially Equivalent |
| Weight | 88 g | 89 g | Substantially Equivalent |
| Features: | | | |
| No direct affect on the
cornea | Yes | Yes | Substantially Equivalent |
| Portability | Yes | Yes | Substantially Equivalent |
| Displays independent from
corneas crookedness | Yes | Yes | Substantially Equivalent |
| Digital IOP Indication | Yes | Yes | Substantially Equivalent |
| Short time measurement | Yes | Yes | Substantially Equivalent |
| Sterilization is not required | Yes | Yes | Substantially Equivalent |
| Anesthesia is not required | Yes | Yes | Substantially Equivalent |
Discussion of substantial equivalence
The indications for use, features, materials and technical parameters (with the exception of the measurement method) are either the same or substantially equivalent to each other. The difference between the two devices are the measurement methods. The difference in the measurement method does not impact safety or effectiveness
All tonometers are known to take IOP measurements indirectly, by measuring the response of the eye coats to a mechanical measuring stimulus.
The main feature of transpalpebral tonometry is the damping effect of the eyelid. The effect is balanced out by compressing the eyelid before the procedure, in the same manner as an eyelid is compressed (pushed against) by fingers before palpation.
The operating principle of DIATON is based on elastic interaction of the freely falling rod with the eyeball through eyelid.
Interaction of the rod with eyeball is the only part that is essential. The duration of this contact is less than 0.1 sec. The mechanical interference (movement of the eye, tremor of the operator's hand, etc.) in this fraction of time has a significant
7
impact on the measurement result, which is a defect common for all dynamic pulse methods of measurement.
Meanwhile, EASYTON enables a measuring process of a different kind. In this case, the evelid is compressed before the measurement is started, and remains in this compressed state up until the measurement completion. The measuring process implies continuous active interaction of the rod with the eyeball (average time of contact is 1 sec.).
The amplitude of the free vibrations is of minor importance: it is the frequency that counts, which depends on the mass of the rigidity of the eye (IOP). Stability of the result is obtained by filtering 10-20 measuring periods produced during one measurement cycle.
Thus, the measuring method provided by EASYTON successfully combines the advantages of both static and dynamic methods.
The measuring action of EASYTON, just as that of DIATON, is exerted through eyelid in the scleral area corresponding to corona ciliaris in the meridian of 12 hours, and is perceived as mild vibration. No anesthesia is required prior to the measurement, which is taken in one second.
In addition, an improved method of disinfection with Rapicide RA raster registered in the US market was analyzed and laboratory confirmed.
Reference (comparative) studies were carried out on the measurement of IOP with the Tonometer Easyton and Tonometer Goldman in accordance with the requirements of ANSI Z80.10-2014 (ISO 8612) on eyes of representative groups that take into account options for the anatomical features of the eyelids. Studies were conducted on representatives of:
-with low stiffness of the eyelids, in the Glaucoma Community of Russia, IPO (Moscow, Russia);
-with epicanthus, in the Regional Medical Center (Karaganda, Kazakhstan) and TENSV Clinic, LLP (Karaganda, Kazakhstan);
- with the stiffness rigidity of the eyelids, in Hospital Park (Gurgaon, New Delhi, India).
The study showed that the results of measurements with the tonometer Easyton and the Goldman tonometer are in the acceptable ranges of measurement error (no more than ± 5%) for all types of eyes examined.
Based on the above comparisons we have determined that the difference in measuring does not impact safety or effectiveness. Therefore we conclude that the subject device and predicate device are substantially equivalent.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
8
Biocompatibility testing
We have assessed all of our patient contacting materials for biocompatibility requirements in accordance with the Mav 1, 1995 FDA Biocompatibility Guidance, the FDA-modified matrix of the "International Standard ISO-10993", "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", including the flow chart entitled "Biocompatibility Flow Chart for the Selection of Toxicity Tests of 510(k)'s.
We have determined that the patient contacting portion of the device is a body surface contacting device for less than 24 hours.
The patient contacting materials are:
Tonometer stock made of Alloy D16 complies with requirements of GOST 21488-97 with a chemical composition according to GOST 4784 and there is a chance of contact Tonometer ring made of BRAZH9-4 complies with requirements of GOST 1628-78 with chemical composition according to GOST 18175.- working part tonometer (1).
Additionally, an investigation was carried out on non-contacting parts of the Tonometer to completely eliminate hazards. ABS RESIN HI-121- cover, case (2).
The device passed all biocompatibility tests.
Validation of Cleaning and Sterization Methods
The device is not sterilized. Infection measures are analyzed of investigation relating to the validation process.
Disinfection instructions for the buffer ring and of the rod is included in the owner's manual. These parts are reusable.
Electrical safety and EMC testing were conducted on the complies with: the IEC 60601-1, IEC 60601-2-2 standards for safety and the IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8, CISPR 11 standards for EMC.
Software Verification
The software level of concern for this device type is moderate based on the answers to the questions in the guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Clinical Performance
To account for anatomical differences of eyelid structures in the indicated patient population, three comparative studies were carried out for measurements of IOP using the Easyton and Goldmann Applanation Tonometers. All three studies were conducted in accordance with the requirements of ANSI Z80.10-2014 and two of the studies included additional measurements of high astigmatic eves. Brief descriptions and results of these comparative studies are provided below:
9
-
- "Low stiffness eyelids study". In this study we enrolled a Caucasian population with low stiffness of the eyelids. The study was conducted in the Glaucoma Community of Russia, IPO (Moscow, Russia). The study was conducted in 156 patients (eyes) distributed in 3 IOP ranges, as follows:
| IOP Range | #of eyes (≤3D Cyl) | #of eyes (>3D Cyl) |
|---|---|---|
| 7 to 16 | 46 | 10 |
| >16 to 23 | 40 | 10 |
The comparative study results are shown in the following graphs:
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Image /page/10/Figure/1 description: The image contains two plots comparing TVGD-02 with Goldman. The top plot is a scatter plot with a regression line, showing the relationship between the two variables. The bottom plot is a Bland-Altman plot, which shows the difference between the two variables against their mean. The Bland-Altman plot includes lines indicating the bias, as well as the +95% confidence level and +1.96 standard deviations.
Appendix 1. The regression and Bland-Altman graphs studies for representatives with low stiffess of the eyelids.
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-
- "Epicanthus study". In this study we enrolled an Asian population with epicanthal fold of the eyelid. The study was conducted in Regional Medical Center (Karaganda, Kazakhstan) and TENSV Clinic, LLP (Karaganda, Kazakhstan). The study was conducted in 150 patients (eyes) distributed in 3 IOP ranges, as follows
| IOP Range | #of eyes (≤3D Cyl) | #of eyes (>3D Cyl) |
|---|---|---|
| 7 to 16 | 40 | 10 |
| >16 to 16 to |