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

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
University of Southern California
Information provided by (Responsible Party):
Optos, PLC.
ClinicalTrials.gov Identifier:
NCT01692938
First received: September 21, 2012
Last updated: October 28, 2015
Last verified: September 2015
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO

Resource links provided by NLM:


Further study details as provided by Optos, PLC.:

Primary Outcome Measures:
  • Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 32
Study Start Date: October 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
No Retinal Disease
Retinal Disease

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692938

Locations
United States, Florida
Retina Group of Florida
Fort Lauderdale, Florida, United States, 33334
United States, Maryland
Johns Hopkins Unversity
Baltimore, Maryland, United States, 21287
United States, Texas
Valley Retina Institute
McAllen, Texas, United States, 78503
Sponsors and Collaborators
Optos, PLC.
Johns Hopkins University
University of Southern California
Investigators
Principal Investigator: Quan Nguyen Johns Hopkins University
  More Information

Responsible Party: Optos, PLC.
ClinicalTrials.gov Identifier: NCT01692938     History of Changes
Other Study ID Numbers: OPT1001 
Study First Received: September 21, 2012
Results First Received: July 19, 2013
Last Updated: October 28, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Retinal Diseases
Atrophy
Diabetic Retinopathy
Retinal Vein Occlusion
Retinal Perforations
Geographic Atrophy
Epiretinal Membrane
Central Serous Chorioretinopathy
Retinal Degeneration
Eye Diseases
Pathological Conditions, Anatomical
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis

ClinicalTrials.gov processed this record on September 26, 2016