Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO

Optos

Status: Completed

Conditions: Age-Related Macular Degeneration; Geographic Atrophy; Macular Edema; Central Serous Retinopathy; Macular Hole; Retinal Vein Occlusion; Epiretinal Membrane; Diabetic Retinopathy; Pattern Dystrophy of Macula

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01692938

OPT1001

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

32 participants in 2 patient groups

No Retinal Disease

Retinal Disease