Clinical trial NCT01692938: Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO
Official title: Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
name: University of Southern California
First posted: 2012-09-26
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations
timeFrame: 1 Month
measure: 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.
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Unversity
state: Maryland
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
Study officials:
affiliation: Johns Hopkins University
name: Quan Nguyen
role: PRINCIPAL_INVESTIGATOR
References: