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

NCT ID: NCT01692938

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2012-11-30

Brief 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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

No Retinal Disease

No interventions assigned to this group

Retinal Disease

No interventions assigned to this group

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: collaborator

Optos, PLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quan Nguyen

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Retina Group of Florida

Fort Lauderdale, Florida, United States

Johns Hopkins Unversity

Baltimore, Maryland, United States

Valley Retina Institute

McAllen, Texas, United States

Countries

United States

Other Identifiers

OPT1001

Identifier Type: -

Identifier Source: org_study_id