Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01995435
Other study ID # SPL-321-REF
Secondary ID
Status Completed
Phase N/A
First received November 12, 2013
Last updated September 3, 2015
Start date February 2015
Est. completion date June 2015

Study information

Verified date September 2015
Source Lee, Steven, M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic


Intervention

Device:
Telemedicine refraction

Traditional refraction


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lee, Steven, M.D.

Outcome

Type Measure Description Time frame Safety issue
Other patient satisfaction from telerefraction an average of 1 year No
Primary refraction in diopters over telemedicine compared standard phoropter refraction an average of 1 year Yes
Secondary telemedicine refraction results beyond dioptric readings to see if there are other uses for telemedicine refraction results an average of 1 year Yes