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

This study is currently recruiting participants.
Verified September 2012 by Optos, PLC.
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, 2012
Last verified: September 2012
  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.:

Estimated Enrollment: 24
Study Start Date: October 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692938

Locations
United States, California
USC, Doheny Eye Institute Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Srinivas Sadda, MD         
Principal Investigator: Srinivas Sadda, MD         
United States, Florida
Retina Group of Florida Recruiting
Fort Lauderdale, Florida, United States, 33334
Contact: Lawrence S Halperin, MD    954-776-6880      
Principal Investigator: Lawrence S Halperin, MD         
United States, Maryland
Johns Hopkins Unversity Recruiting
Baltimore, Maryland, United States, 21287
Contact: Quan Nguyen, MD    410-502-9821      
Contact: Hongting Liu         
Principal Investigator: Quan Nguyen, MD         
United States, Texas
Valley Retina Institute Recruiting
McAllen, Texas, United States, 78503
Contact: Victor Gonzalez, MD    956-631-8875      
Principal Investigator: Victor Gonzalez, MD         
Sponsors and Collaborators
Optos, PLC.
Johns Hopkins University
University of Southern California
Investigators
Principal Investigator: Quan Nguyen Johns Hopkins University
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on April 14, 2014