Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements
Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 Ophthalmic Instruments -Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)
1 other identifier
observational
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 23, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 8, 2022
June 1, 2022
3 months
April 23, 2014
June 6, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Male and female adults 18+ years of age
Eligibility Criteria
Ophthalmology practice
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andover Eye Associates
Andover, Massachusetts, 01810, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2014
First Posted
May 14, 2014
Study Start
April 1, 2014
Primary Completion
July 1, 2014
Study Completion
December 1, 2014
Last Updated
June 8, 2022
Record last verified: 2022-06