Refraction Determination Analysis

This study is not yet open for participant recruitment.
Verified December 2013 by Lee, Steven, M.D.
Sponsor:
Information provided by (Responsible Party):
Steven Lee, OD, University of Chicago
ClinicalTrials.gov Identifier:
NCT01995435
First received: November 12, 2013
Last updated: December 13, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Lee, Steven, M.D.:

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

Secondary Outcome Measures:
  • telemedicine refraction results beyond dioptric readings [ Time Frame: an average of 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: January 2014
Estimated Primary Completion Date: January 2014 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01995435

Contacts
Contact: Steven Lee 312-283-4560 doctorstevenlee@gmail.com

Locations
United States, Illinois
Duchossois Center for Advanced Medicine Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Michael Saidel, MD         
Sponsors and Collaborators
Lee, Steven, M.D.
  More Information

No publications provided

Responsible Party: Steven Lee, OD, Optometrist, University of Chicago
ClinicalTrials.gov Identifier: NCT01995435     History of Changes
Other Study ID Numbers: SPL-321-REF
Study First Received: November 12, 2013
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014