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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33334
      • Retina Group of Florida
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Unversity
  • Texas
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Twenty-four subjects, 12 without retinal disease (Cohort 1) and 12 with retinal disease (Cohort 2) will be recruited. Any subjects that do not comply with or complete the study protocol will be replaced to ensure that a total of 24 subjects complete the protocol. Subjects will be screened and recruited based on the Inclusion/Exclusion criteria outlined within this protocol. Subjects fulfilling the stated criteria and who are willing to comply must sign an informed consent prior form to study participation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
No Retinal Disease
Retinal Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations	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.	1 Month
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.	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.	1 Month

Collaborators and Investigators

• Sponsor: Optos, PLC
• Collaborators: Johns Hopkins University; University of Southern California
• Investigators: Principal Investigator: Quan Nguyen, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: September 21, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Retinal Diseases; Diabetic Retinopathy; Macular Edema; Retinal Vein Occlusion; Geographic Atrophy; Retinal Perforations; Epiretinal Membrane; Central Serous Chorioretinopathy
• Other Study ID Numbers: OPT1001