Clinical Trials Logo
  1. Home
  2. Intraocular Pressure
  3. NCT03439774

Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P

Intraocular Pressure Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03439774
Study type Observational
Source Topcon Corporation
Contact
Status Completed
Phase
Start date May 5, 2017
Completion date June 30, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT03494257 - Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification N/A
Completed NCT03016234 - IOP Changes With Different Anesthetic Agents During Laparoscopic Colorectal Surgery N/A
Completed NCT04863209 - Effect of Osteopathic Techiniques on Intraocular Pressure N/A
Completed NCT03139708 - The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients Phase 1
Completed NCT02646033 - Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position
Recruiting NCT02697825 - Intraocular Pressure Versus Optic Nerve Sheath Diameter N/A
Completed NCT02985567 - An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children N/A
Withdrawn NCT00837226 - Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure (IOP) N/A
Completed NCT02136589 - Effect of NSAID on Travoprost-induced Conjunctival Hyperemia and IOP Reduction in Normal Eyes Phase 4
Completed NCT03123614 - Loteprednol vs. Prednisolone and Fluorometholone Phase 4
Completed NCT05763056 - Effects of Intubation on Intra-ocular Pressure and Optic Nerve Sheath Diameter N/A
Completed NCT03359200 - Analysis of the Microbiota in Goldmann Applanation Tonometers at a Reference Service in Goiânia N/A
Withdrawn NCT02558309 - Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure N/A
Completed NCT02816905 - Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery Phase 4
Completed NCT01786954 - iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery N/A
Completed NCT00552019 - Intraocular Pressure (IOP) Assessed by Dynamic Contour Tonometer (DCT) and Goldman Applanation Tonometry (GAT) N/A
Completed NCT00428740 - Long-Term IOP Fluctuation and VF Progression After Triple Procedure N/A
Completed NCT04360369 - Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry N/A
Completed NCT04521140 - Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery Phase 4
Completed NCT05167773 - Clinical Study of the Topcon Tonometer TRK-3