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Refraction Determination Analysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01995435
First Posted: November 26, 2013
Last Update Posted: September 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Coad Dow, MD, Chippewa Valley Eye Clinic
  Purpose
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.

Condition Intervention
Myopia, Hyperopia, Astigmatism, Presbyopia, Eye Strain, Device: Telemedicine refraction Device: Traditional refraction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic

Further study details as provided by Coad Dow, MD, Chippewa Valley Eye Clinic:

Primary Outcome Measures:
  • refraction in diopters over telemedicine compared standard phoropter refraction [ Time Frame: an average of 1 year ]

Secondary Outcome Measures:
  • telemedicine refraction results beyond dioptric readings [ Time Frame: an average of 1 year ]
    to see if there are other uses for telemedicine refraction results


Other Outcome Measures:
  • patient satisfaction from telerefraction [ Time Frame: an average of 1 year ]

Enrollment: 30
Study Start Date: February 2015
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemedicine refraction before traditional refraction
We will first refract an individual using telemedicine refraction, and then refract them using a traditional refraction method.
Device: Telemedicine refraction
Other Names:
  • Glasses,
  • Contact lenses,
  • Refractive surgery,
Device: Traditional refraction
Experimental: Traditional refraction before telemedicine refraction
We will first refract an individual using a traditional refraction, and then refract them using a telemedicine refraction method.
Device: Telemedicine refraction
Other Names:
  • Glasses,
  • Contact lenses,
  • Refractive surgery,
Device: Traditional refraction

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Coad Dow, MD, Investigator, Chippewa Valley Eye Clinic
ClinicalTrials.gov Identifier: NCT01995435     History of Changes
Other Study ID Numbers: SPL-321-REF
First Submitted: November 12, 2013
First Posted: November 26, 2013
Last Update Posted: September 7, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Astigmatism
Presbyopia
Hyperopia
Asthenopia
Refractive Errors
Eye Diseases