IOP Device Comparison Study

August 31, 2021 updated by: Lawson Health Research Institute

Comparison of Intraocular Pressure Measurements Between Icare PRO, Icare ic200, and Goldmann Applanation Tonometer

Intraocular pressure measurement (IOP) is part of a routine eye examination. High and low eye pressure may be linked to certain eye conditions such as glaucoma. The current gold standard for IOP measurement is a technique called Goldmann Applanation Tonometry (GAT). GAT requires the use of a Goldmann applanation tonometer mounted on a slit lamp. Apart from GAT, there are many other devices that can be used to measure IOP, including the iCare tonometers. In this prospective study, investigators will be measuring participant's IOP with GAT, Icare PRO, and Icare ic200 tonometers to see if there is an agreement in IOP between the different devices. Investigator will also look if there is a concordance between different tonometers in low, moderate and high IOP range. Given the postural requirements for performing GAT, patients with higher body mass index (BMI) tend to have difficulties with proper positioning at the slit lamp that may lead to inaccurate GAT measurements. To this end, investigators will analyze the effect of BMI on IOP measurements with different devices. Additionally, comfort level of the patients with different tonometry devices will be recorded using a visual analog scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intraocular pressure measurement (IOP) is a vital part of the routine eye examination. High and low eye pressure may be associated with various ocular pathologies, including glaucoma. The current gold standard for IOP measurement is Goldmann Applanation Tonometry (GAT). To perform measurements with GAT, topical anaesthetic and fluorescein eye drops are applied to the eye. The Goldmann tonometer tip directly contacts the cornea and measures the intraocular pressure by the Imbert-Fick principle. IOP measurement is generally performed by a trained and experienced ophthalmologist or ophthalmic technician on patients in an upright position. There may be minor discomfort associated with the use of topical anaesthetic in this technique.

Icare tonometers are a new class of rebound tonometers used for IOP measurements. A disposable tip of the Icare tonometer is propelled towards the cornea and the deceleration of the tip is measured to calculate the IOP. The Icare series of devices are hand-held tonometers, which are easy to operate and do not require topical anaesthesia for IOP measurements.

Despite being the most reliable and clinically validated method to measure IOP, GAT has several limitations. First, it requires extensive training and experience to accurately measure IOP. Moreover, IOP measurement with GAT may be associated with minor discomfort due to the need for topical anaesthesia. Apart from that, GAT is not a portable device and the patient needs to be seated upright, making it difficult to perform in certain populations, such as pediatric, elderly and those with high BMI. Several hand-held tonometers are available, including the Icare series. These tonometers allow for quick, portable, and arguably easier IOP measurements. These tonometers do not require as rigorous training to use. However, there is an inconsistency in the data to verify if the IOP measurements by Icare is in concordance with GAT measurements. Recent Meta-analysis by Rödter and colleagues neither confirm nor deny the agreement between Icare and GAT tonometers.

The purpose of the current study is to prospectively evaluate and determine the relationship of the IOP measurements obtained by Icare PRO, Icare ic200, and GAT. The study will evaluate IOP measurements in different IOP ranges (low: 7-15mmHg, Moderate: 16- 22mmHg, High: 23-60 mmHg) as well as the effects of central corneal thickness and BMI on IOP measurements. Patient comfort during tonometry will be measured using a visual analogue scale. To date, this will be the first study in Canada to compare IOP measurements between Icare PRO, Icare ic200, and GAT in different IOP ranges. Additionally, as the Icare ic200 is a new device, this will be the first study to perform a comparative functional analysis of the Icare ic200 versus GAT.

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Ivey Eye Institute at St Joseph hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Glaucoma suspects or patients who are older than 18 years are invited to participate in this study.

Description

Inclusion Criteria:

  • Age greater than 18 years
  • Willingness to participate in all study procedures, along with signed written consent

Exclusion Criteria:

  • Age younger than 18 years
  • Participants with corneal defects (edema, scarring, cicatrix, opacity)
  • Participants with epithelial lesions, prior refractive surgery and keratoplasty surgery
  • Participants having corneal astigmatism ≥ 3D
  • Participants who wear contact lenses
  • Participants with proliferative diabetic retinopathy, Uveitis
  • Participants who are unable to have IOP measured by Goldmann Tonometry
  • Inability to provide informed consent
  • Participants with proliferative diabetic retinopathy, Uveitis
  • Participation in a clinical trial with investigational products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glaucoma suspect or patients
Patients who has or suspected Glaucoma will be approached for the recruitment into this study. IOP will be measured in the sitting position with Icare tonometers in a random order in both the eyes. IOP measurements by GAT will be taken after Icare measurements followed by CCT recording with ultrasound pachymeter.
Device: Icare Tonometer
Icare tonometers are a new class of rebound tonometers for IOP measurements. The Icare series of tonometers are hand-held tonometers, which are easy to operate and generally do not require topical anaesthesia for IOP measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance in IOP between GAT and Icare ic200
Time Frame: It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Primary objective of this study is to compare overall Mean IOP between GAT and Icare ic200
It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance in IOP between GAT and Icare PRO
Time Frame: It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
To compare the overall IOP measurements between GAT and Icare PRO.
It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Concordance among tonometers in low IOP range
Time Frame: It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
To compare IOP measurements between GAT and Icare PRO/Icare ic200 in low IOP range (7-15 mmHg).
It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Concordance among tonometers in medium IOP range
Time Frame: It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
To compare IOP measurements between GAT and Icare PRO/Icare ic200 in medium IOP range (16-22 mmHg).
It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Concordance among tonometers in high IOP range
Time Frame: It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
To compare IOP measurements between GAT and Icare PRO/Icare ic200 in high IOP range (23-60 mmHg).
It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Proportion of Icare IOP measurements with GAT recordings
Time Frame: It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
To determine the proportion of IOP measurements from Icare PRO and Icare ic200 that are within ±2 mmHg, ±3 mmHg and ±5 mmHg of the GAT measurements.
It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Corelation between GAT and Icare Tonometers
Time Frame: It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
To find the correlation in the IOP measurement between GAT and Icare PRO and also between GAT and Icare ic200.
It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Corelation between central corneal thickness (CCT) and IOP
Time Frame: It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
To evaluate the effect of central corneal thickness (CCT) on IOP measurement by GAT, Icare PRO and Icare ic200.
It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Effect of BMI on IOP
Time Frame: It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
To evaluate the effects of BMI on IOP measurement by GAT, Icare PRO, Icare ic200.
It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Patient comfort during tonometry
Time Frame: It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
To evaluate patient comfort during tonometry measurements with each device using a Visual Analog Scale (VAS).
It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Tony Lin, MD, Ivey Eye Institute- St Joseph's hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

December 21, 2019

First Submitted That Met QC Criteria

December 21, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Tonometry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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