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Refraction Determination Analysis

Primary Purpose

Myopia,, Hyperopia,, Astigmatism,

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telemedicine refraction
Traditional refraction
Sponsored by
Lee, Steven, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myopia,

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-40 years old
  • healthy eyes

Exclusion Criteria:

  • mid level ocular diseases (glaucoma, hypertension, retinal issues)
  • psychiatric disorders
  • brain tumor or history of
  • under 18, or over 40 years old

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Telemedicine refraction before traditional refraction

    Traditional refraction before telemedicine refraction

    Arm Description

    We will first refract an individual using telemedicine refraction, and then refract them using a traditional refraction method.

    We will first refract an individual using a traditional refraction, and then refract them using a telemedicine refraction method.

    Outcomes

    Primary Outcome Measures

    refraction in diopters over telemedicine compared standard phoropter refraction

    Secondary Outcome Measures

    telemedicine refraction results beyond dioptric readings
    to see if there are other uses for telemedicine refraction results

    Full Information

    First Posted
    November 12, 2013
    Last Updated
    September 3, 2015
    Sponsor
    Lee, Steven, M.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01995435
    Brief Title
    Refraction Determination Analysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lee, Steven, M.D.

    4. Oversight

    5. Study Description

    Brief Summary
    Correlating the accuracy of a refraction done over telemedicine to that of a standard refraction, with a study hypothesis that the results will be equivalent.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia,, Hyperopia,, Astigmatism,, Presbyopia,, Eye Strain,

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Telemedicine refraction before traditional refraction
    Arm Type
    Experimental
    Arm Description
    We will first refract an individual using telemedicine refraction, and then refract them using a traditional refraction method.
    Arm Title
    Traditional refraction before telemedicine refraction
    Arm Type
    Experimental
    Arm Description
    We will first refract an individual using a traditional refraction, and then refract them using a telemedicine refraction method.
    Intervention Type
    Device
    Intervention Name(s)
    Telemedicine refraction
    Other Intervention Name(s)
    Glasses,, Contact lenses,, Refractive surgery,
    Intervention Type
    Device
    Intervention Name(s)
    Traditional refraction
    Primary Outcome Measure Information:
    Title
    refraction in diopters over telemedicine compared standard phoropter refraction
    Time Frame
    an average of 1 year
    Secondary Outcome Measure Information:
    Title
    telemedicine refraction results beyond dioptric readings
    Description
    to see if there are other uses for telemedicine refraction results
    Time Frame
    an average of 1 year
    Other Pre-specified Outcome Measures:
    Title
    patient satisfaction from telerefraction
    Time Frame
    an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18-40 years old healthy eyes Exclusion Criteria: mid level ocular diseases (glaucoma, hypertension, retinal issues) psychiatric disorders brain tumor or history of under 18, or over 40 years old

    12. IPD Sharing Statement

    Learn more about this trial

    Refraction Determination Analysis

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