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NCT03439774 · ClinicalTrials.gov registry record
Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P
A clinical trial, sponsored by Topcon Medical Systems.
- Completed
- Registry status
- 345
- Enrollment target
NCT03439774: Completed study, sponsored by Topcon Medical Systems.
NCT03439774 is a clinical trial that has completed, run by Topcon Medical Systems. The registered enrollment target is 345 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03439774 has completed, sponsored by Topcon Medical Systems.
- COMPLETED
- Registry status
- 345 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Agreement of the measured IOP between the test devices and the predicate device for the tonometer function of CT-800 and TRK-2P. Presentation of results and analyses will include descriptive statistics (mean, standard deviation, limits of agreement), Bland-Altman plot and linear regression.
Interventions
- DEVICE Topcon CT-800
- DEVICE Topcon TRK-2P
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2017-05-05 |
| Est. Completion | 2018-06-30 |
What the finished NCT03439774 record still lists
NCT03439774 is an observational study that tracks outcomes without assigning an intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Topcon CT-800 is the first listed.
NCT03439774 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03439774 about?
NCT03439774 is a clinical study titled "Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P". 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 stud...
What is the current status of trial NCT03439774?
This trial is currently completed. The enrollment target is 345 participants. The study started on 2017-05-05. Estimated completion is 2018-06-30.
What interventions are being tested in trial NCT03439774?
The interventions under investigation include: Topcon CT-800 (DEVICE), Topcon TRK-2P (DEVICE).
Who is sponsoring clinical trial NCT03439774?
This trial is sponsored by Topcon Medical Systems, which has 24 total clinical trials registered on ClinicalTrials.gov.
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