Brief Title
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
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.
Study Type
Observational
Primary Outcome
Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations
Condition
Age-Related Macular Degeneration
Study Arms / Comparison Groups
No Retinal Disease
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
32
Start Date
October 2012
Completion Date
November 2012
Primary Completion Date
November 2012
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.
Gender
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Quan Nguyen, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01692938
Organization ID
OPT1001
Responsible Party
Sponsor
Study Sponsor
Optos, PLC
Collaborators
Johns Hopkins University
Study Sponsor
Quan Nguyen, Principal Investigator, Johns Hopkins University
Verification Date
April 2017