Study to Compare Kowa OCT Bi-μ and the Optovue iVue 100
Not Applicable
Completed
- Conditions
- HealthyRetinal DiseaseGlaucoma
- Interventions
- Device: KOWA OCT Bi-µDevice: Optovue iVue 100
- Registration Number
- NCT03505567
- Lead Sponsor
- Kowa Research Institute, Inc.
- Brief Summary
This study is a prospective comparative study to gather pilot agreement and precision data in normal subjects, subjects with glaucoma, and subjects with retinal disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Random Sequenced Interventions KOWA OCT Bi-µ Participants from three condition groups (normal, glaucoma, retinal disease) assigned two interventions (Kowa OCT Bi-μ and the Optovue iVue 100) under random sequence assignments. Random Sequenced Interventions Optovue iVue 100 Participants from three condition groups (normal, glaucoma, retinal disease) assigned two interventions (Kowa OCT Bi-μ and the Optovue iVue 100) under random sequence assignments.
- Primary Outcome Measures
Name Time Method Compare KOWA OCT Bi-μ and Optovue iVue 100 1-2 days 1. Full retinal thickness \[Early Treatment Diabetic Retinopathy Study (ETDRS) Grid\]
2. Full retinal thickness (Manual Measurement)
3. Retinal nerve fiber layer thickness
4. Ganglion cell complex thickness
5. Full retinal thickness map
- Secondary Outcome Measures
Name Time Method Safety: Evaluate any adverse events found during the clinical study 1-2 days Evaluate any adverse events found during the clinical study
Trial Locations
- Locations (1)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States