At a glance
ClinicalIndex Comparison RecordN/ACompleted· 48 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study
In Brief
An observational study for Retinal Disease and Glaucoma. Completed, enrolled 48 participants across 4 sites.
Detailed Summary
The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRetinal Disease, Glaucoma
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
Primary CompletionNov 2008
First PostedNov 2008
TodayJul 2026
First PostedNov 17, 2008
Enrollment StartOct 1, 2008
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.6 years ago