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

Completed

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

• Registration Number: NCT01692938
• Lead Sponsor: Optos, PLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-26
• Study Start: 2012-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2013-07-19
• Results First Submitted QC: 2015-10-28
• Results First Posted: 2015-11-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations	1 Month	A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.
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.	1 Month	A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.

Trial Locations

Locations (3)

Retina Group of Florida; 🇺🇸 Fort Lauderdale, Florida, United States

Johns Hopkins Unversity; 🇺🇸 Baltimore, Maryland, United States

Valley Retina Institute; 🇺🇸 McAllen, Texas, United States