Refraction Determination Analysis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Lee, Steven, M.D.
Sponsor:
Information provided by (Responsible Party):
Steven Lee, OD, Institut de Recherche Clinique sur les Cancers et le Sang
ClinicalTrials.gov Identifier:
NCT01995435
First received: November 12, 2013
Last updated: May 15, 2014
Last verified: May 2014
  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: June 2014
Estimated Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995435

Contacts
Contact: Eric Pitt 470-222-5327 info@opternative.com

Sponsors and Collaborators
Lee, Steven, M.D.
  More Information

No publications provided

Responsible Party: Steven Lee, OD, Investigator, Institut de Recherche Clinique sur les Cancers et le Sang
ClinicalTrials.gov Identifier: NCT01995435     History of Changes
Other Study ID Numbers: SPL-321-REF
Study First Received: November 12, 2013
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Astigmatism
Presbyopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on October 23, 2014