Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/22/2018 |
| Start Date: | May 5, 2017 |
| End Date: | February 2018 |
| Contact: | James Lorkowksi |
| Email: | jlorkowski@topcon.com |
| Phone: | 201-599-5187 |
Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance to ANSI Z80.10-2014 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 Topcon TRK-2P With the Topcon SP-1P (Predicate)
The study will assess the CT-800 and TRK-2P for conformity to ANSI Z80.10-2014 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. This
clinical device study will also assess the substantial equivalence of TRK-2P to a predicate
device in regard to pachymetry.
Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket
Notification [510(k)] Submissions, and to the applicable Supplemental Information Sheet. This
clinical device study will also assess the substantial equivalence of TRK-2P to a predicate
device in regard to pachymetry.
Inclusion Criteria:
1. be at least 18 years of age of either sex and any race or ethnicity;
2. be willing and able to provide written informed consent prior to any study procedures
being performed;
3. be willing and able to follow all instructions and attend all study visits;
Exclusion Criteria:
1. have only one functional eye;
2. have poor or eccentric fixation in either eye;
3. have corneal scarring or have had corneal surgery, including corneal laser surgery in
either eye;
4. have microphthalmos in either eye;
5. have buphthalmos in either eye;
6. be a 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;
7. have dry eyes, meaning having been diagnosed by a physician with dry eyes and
currently using a prescribed medication or daily use of an artificial tear;
8. be a lid squeezer - blepharospasm;
9. have nystagmus in either eye;
10. have keratoconus in either eye;
11. have any other corneal or conjunctival pathology or infection in either eye;
12. have a 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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