N/A
N=32
Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO
Age-Related Macular Degeneration · Geographic Atrophy · Diabetic Retinopathy · Macular Edema · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01692938 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations — 16.16; 12.23 decibels
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Optos, PLC
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations |
16.16; 12.23 | — |
| PRIMARY Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination. |
16.16; 12.23; 16.16; 12.23 | — |
Summary
To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO. The study will assess variability across measurements taken by three different operator-device configuration across clinical sites, variability between subjects within a given operator-device configuration, and variability within a subject for a single operator-device configuration.
Eligibility Criteria
Inclusion Criteria
- Subject must be 21 years of age or older.
- Subjects recruited to Cohort 1 will have no known retinal disease except for refractive errors (-7.5 D to +7.5 diopters).Subjects who are recruited to Cohort 2 will have one or more of the following retinal pathologies: early and intermediate Age-Related Macular Degeneration, Geographic Atrophy, Diabetic Retinopathy (mild, moderate, severe), Macular Edema secondary to Diabetes, Retinal Vein Occlusion, Central Serous Retinopathy, Pattern Dystrophy, Epiretinal Membrane or Macular Hole.
- Subjects who have signed an informed consent form.
- Subjects who can comply with the protocol.
Exclusion Criteria
- Subjects younger than 21 years of age.
- Subjects who cannot comply with the protocol.
- Subjects who cannot complete the Simple Test procedures
- Subjects who are not available to be testing 3 times during the day (Morning, Mid - Day, and Afternoon).
- Subjects with visual acuity worse than 20/100 (Best Corrected).
- Subjects with dense media opacities.
- Ocular surgery anticipated on the day of the study visit.
Data sourced from ClinicalTrials.gov (NCT01692938). 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.