NCT01995435

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

November 12, 2013

Last Update Submit

September 3, 2015

Conditions

Myopia,Hyperopia,Astigmatism,Presbyopia,Eye Strain,

Outcome Measures

Primary Outcomes (1)

  • refraction in diopters over telemedicine compared standard phoropter refraction

    an average of 1 year

Secondary Outcomes (1)

  • telemedicine refraction results beyond dioptric readings

    an average of 1 year

Other Outcomes (1)

  • patient satisfaction from telerefraction

    an average of 1 year

Study Arms (2)

Telemedicine refraction before traditional refraction

EXPERIMENTAL

We will first refract an individual using telemedicine refraction, and then refract them using a traditional refraction method.

Device: Telemedicine refractionDevice: Traditional refraction

Traditional refraction before telemedicine refraction

EXPERIMENTAL

We will first refract an individual using a traditional refraction, and then refract them using a telemedicine refraction method.

Device: Telemedicine refractionDevice: Traditional refraction

Interventions

Telemedicine refractionDEVICE
Also known as: Glasses,, Contact lenses,, Refractive surgery,
Telemedicine refraction before traditional refractionTraditional refraction before telemedicine refraction
Traditional refractionDEVICE
Telemedicine refraction before traditional refractionTraditional refraction before telemedicine refraction

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • healthy eyes

You may not qualify if:

  • mid level ocular diseases (glaucoma, hypertension, retinal issues)
  • psychiatric disorders
  • brain tumor or history of
  • under 18, or over 40 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyopiaHyperopiaAstigmatismPresbyopiaAsthenopia

Interventions

EyeglassesContact LensesRefractive Surgical Procedures

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 26, 2013

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09