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

Pattern Dystrophy of Macula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692938
• Other study ID #: OPT1001
• Status: Completed
• Phase: N/A
• First received: September 21, 2012
• Last updated: October 28, 2015
• Start date: October 2012
• Est. completion date: November 2012

Study information

• Verified date: September 2015
• Source: Optos, PLC.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-Related Macular Degeneration,
• Central Serous Chorioretinopathy
• Central Serous Retinopathy,
• Diabetic Retinopathy
• Diabetic Retinopathy,
• Epiretinal Membrane
• Epiretinal Membrane,
• Geographic Atrophy
• Geographic Atrophy,
• Macular Degeneration
• Macular Edema
• Macular Edema,
• Macular Hole.
• Pattern Dystrophy of Macula
• Retinal Diseases
• Retinal Vein Occlusion
• Retinal Vein Occlusion,

Locations

Country	Name	City	State
United States	Johns Hopkins Unversity	Baltimore	Maryland
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	Valley Retina Institute	McAllen	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Optos, PLC.	Johns Hopkins University, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No