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NCT03439774
Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P
trial testing Topcon CT-800 in Intraocular Pressure in 345 participants. Completed in 30 June 2018.
17 April 2018
Quick facts
| Lead sponsor | Topcon Medical Systems, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 345 |
| Start date | 5 May 2017 |
| Primary completion | 17 April 2018 |
| Estimated completion | 30 June 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Topcon CT-800
- Topcon TRK-2P
Conditions studied
- Intraocular Pressure — all drugs for Intraocular Pressure →
Sponsor
Topcon Medical Systems, Inc.
Who can join
18 and older, any sex, with Intraocular Pressure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03439774
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06666751 — Anterior Segment Optical Coherence Tomography Microstent Positioning · active not recruiting
- NCT06016712 — The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes · NA · recruiting
- NCT05753137 — Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial · NA · recruiting
- NCT05850936 — Effect of IOP Lowering on Progressive HM · NA · active not recruiting
Other Topcon Medical Systems, Inc. trials
Trials by the same sponsor.
- NCT03107104 — Triton Fundus Autofluorescence and Fluorescein Angiography · completed
- NCT03080714 — Triton Agreement and Precision Study · completed
- NCT02991027 — OCT Image Quality Performance Evaluation · NA · withdrawn
- NCT01809704 — Clinical Validation of New OCT System · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03439774 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Topcon Medical Systems, Inc.
- Last refreshed: 8 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03439774.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing