Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements

Completed

• Conditions: Corneal Pachymetry; Intraocular Pressure

• Registration Number: NCT02138279
• Lead Sponsor: Topcon Medical Systems, Inc.

Brief Summary

The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• At least 18 years of age of either sex and any race or ethnicity;
• Willing and able to provide written informed consent prior to any study procedures being performed;
• Willing and able to follow all instructions and attend all study visits;
• Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart.

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Exclusion Criteria

• Only one functional eye;
• Poor or eccentric fixation;
• Corneal scarring or have had corneal surgery, including corneal laser surgery;
• Microphthalmos;
• Buphthalmos;
• Contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
• Dry eyes, meaning having been diagnoses by a physician with dry eyes and currently using a prescribed medication;
• Lid squeezer - blepharospasm;
• Nystagmus;
• Keratoconus;
• Any other corneal or conjunctival pathology or infection;
• Condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agreement of intraocular pressure measurements from predicate vs. investigational device	Single timepoint - 1 day
Agreement of central corneal thickness measurements from predicate vs. investigational device	Single time point - 1 day

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States