N/A
N=12
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
Subjects Presenting With Normal Eyes
Bottom Line
View on ClinicalTrials.gov: NCT02447133 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: TopQ Cut Off — 2.94; 1.5; 2.14; 17.54 microns
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 3D OCT-1 Maestro (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Topcon Medical Systems, Inc.
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TopQ Cut Off |
2.94; 1.5; 2.14; 17.54; 13.67; 13.67 | — |
Summary
The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.
Eligibility Criteria
Inclusion Criteria
- Participants must be at least 18 years of age
- They must be able to complete all testing (all OCT scans)
- They must volunteer to be in the study and sign the consent form
Exclusion Criteria
- Subject with history of ocular disease or ocular pathology
- TopQ score from baseline OCT scan (i.e., without any ND filters) is below the cut-off value.
Data sourced from ClinicalTrials.gov (NCT02447133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.