Try our beta test site

Refraction Determination Analysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coad Dow, MD, Chippewa Valley Eye Clinic
ClinicalTrials.gov Identifier:
NCT01995435
First received: November 12, 2013
Last updated: September 3, 2015
Last verified: September 2015
  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: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic

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 ]

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

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
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.

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 
Study First Received: November 12, 2013
Last Updated: September 3, 2015

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

ClinicalTrials.gov processed this record on February 23, 2017