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.

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Key information

Conditions

Age-Related Macular Degeneration Cardiovascular Diseases Central Serous Chorioretinopathy Central Serous Retinopathy Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Embolism and Thrombosis Endocrine System Diseases Epiretinal Membrane Eye Diseases Geographic Atrophy Macular Degeneration Macular Edema Macular Hole Pattern Dystrophy of Macula Retinal Degeneration Retinal Diseases Retinal Perforations Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retina Group of Florida, Fort Lauderdale, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations

Time frame: 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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Optos, PLC

Industry

Collaborators

Johns Hopkins University
University of Southern California

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Sep 26, 2012
Registry last updated: May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed