Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/13/2015 |
| Start Date: | April 2014 |
| End Date: | June 2014 |
| Contact: | Jack V. Greiner, DO, PhD |
| Phone: | 978-475-0705 |
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)
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.
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.
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.
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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