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

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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