- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03439774
Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P
June 6, 2022 updated by: Topcon Medical Systems, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
345
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Andover, Massachusetts, United States, 01810
- Andover Eye Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Approximately 250 subjects will have both of their eyes measured.
Description
Inclusion Criteria:
- be at least 18 years of age of either sex and any race or ethnicity;
- be willing and able to provide written informed consent prior to any study procedures being performed;
- be willing and able to follow all instructions and attend all study visits;
Exclusion Criteria:
- have only one functional eye;
- have poor or eccentric fixation in either eye;
- have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye;
- have microphthalmos in either eye;
- have buphthalmos in either eye;
- 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;
- 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;
- be a lid squeezer - blepharospasm;
- have nystagmus in either eye;
- have keratoconus in either eye;
- have any other corneal or conjunctival pathology or infection in either eye;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adults 18 years old or older
|
tonometer
tonometer, pachymeter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement of IOP
Time Frame: 1 day
|
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.
|
1 day
|
Agreement of Corneal Thickness
Time Frame: 1 day
|
Agreement of measured corneal thickness between the test device and the predicate device for the pachymeter function of the TRK-2P.
Presentation of results and analyses will include descriptive statistics (mean, standard deviation, limits of agreement), Bland-Altman plot and Deming regression.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2017
Primary Completion (Actual)
April 17, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
December 8, 2017
First Submitted That Met QC Criteria
February 13, 2018
First Posted (Actual)
February 20, 2018
Study Record Updates
Last Update Posted (Actual)
June 8, 2022
Last Update Submitted That Met QC Criteria
June 6, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Topcon-TON-US-0002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intraocular Pressure
-
University of PittsburghRecruiting
-
The University of Hong KongCompleted
-
Rajiv Gandhi Cancer Institute & Research Center...CompletedIntraocular PressureIndia
-
Prince of Songkla UniversityCompletedIntraocular PressureThailand
-
Astellas Pharma IncCompletedIntraocular PressureUnited States
-
First Affiliated Hospital, Sun Yat-Sen UniversityUnknown
-
Icare Finland OyCompleted
-
Iladevi Cataract and IOL Research CenterCompleted
Clinical Trials on Topcon CT-800
-
Retinal Consultants of ArizonaTopcon CorporationCompleted
-
Federal University of Rio Grande do SulUnknownDiabetic Macular Edema | Branch Retinal Vein Occlusion | Macular Telangiectasia | Chronic Central Serous RetinopathyBrazil
-
Ospedale San RaffaeleUniversity of Rome Tor Vergata; University of Genova; Fondazione G.B. Bietti,...RecruitingMacular Degeneration, Dry | Macular Degeneration, Senile | Laser Burn of Retina | Macular Degeneration IntermediateItaly
-
Zhiwei LiUnknown
-
Shaare Zedek Medical CenterUnknownCarotid Stenosis | Carotid Endarterectomy | Choroid
-
Assiut UniversityNot yet recruiting
-
Topcon Medical Systems, Inc.CompletedMedical Need for Fluorescein Angiography ImagingUnited States
-
Topcon Medical Systems, Inc.Completed
-
Topcon Medical Systems, Inc.CompletedCorneal Endothelial Cell LossUnited States