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

NCT01692938 | Completed Results

• 1 other identifier: OPT1001
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

No Retinal Disease

Retinal Disease

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Optos, PLC: lead
• Johns Hopkins University: collaborator
• University of Southern California: collaborator

Study Sites (3)

Retina Group of Florida

Fort Lauderdale, Florida, 33334, United States

Location

Johns Hopkins Unversity

Baltimore, Maryland, 21287, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy; Diabetic Retinopathy; Macular Edema; Retinal Vein Occlusion; Central Serous Chorioretinopathy; Epiretinal Membrane; Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis

Results Point of Contact

• Title: Quan Nguyen, MD Director of the Stanley M. Truhlsen Eye Institute
• Organization: Stanley M. Truhlsen Eye Institute

quan.nguyen@unmc.edu

402-559-4276

Study Officials

• Quan Nguyen

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 26, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 10, 2017
• Results First Posted: November 30, 2015

Record last verified: 2017-04

Locations

US (3)