Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT03615612
Collaborator
PlenOptika (Other), Aravind Eye Care System (Other)
400
1
2
20.5
19.5

Study Details

Study Description

Brief Summary

At the Aravind Eye Hospital (AEH) in Madurai, India, patients ages 18-40 receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and objective refraction, by way of the QuickSee autorefractor. Patients will then be randomized into one of two treatment plans: receive glasses from objective measure first then subjective measure second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a double blind, case-crossover clinical trial.

Condition or Disease Intervention/Treatment Phase
  • Other: QuickSee refractive error assessment + glasses
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions
Actual Study Start Date :
Dec 15, 2017
Actual Primary Completion Date :
Aug 2, 2019
Actual Study Completion Date :
Aug 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: OR Eyeglasses, then SR

Objective Refraction (OR) Eyeglasses, then Subjective Refraction (SR)

Other: QuickSee refractive error assessment + glasses
QuickSee refractive error assessment + glasses

Other: SR Eyeglasses, then OR

Subjective Refraction (SR) Eyeglasses, then Objective Refraction (OR)

Other: QuickSee refractive error assessment + glasses
QuickSee refractive error assessment + glasses

Outcome Measures

Primary Outcome Measures

  1. Patient Preference [2 years]

    Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria: Participants-

  1. who visit a Vision Center for their eye check-up

  2. who are aged between 18 years and 40 years

Exclusion Criteria: Participants-

  1. whose refractive error is not within the detection range of the QuickSee device: -10 to +10 D

  2. who have a cylindrical power greater than 3 D

  3. who have to travel long distances (beyond 10kms) to the hospital

  4. who choose to buy spectacles that are priced more than Rs. 2000/- per pair

  5. who have speech or hearing impairment

  6. who do not speak the local language, Tamil

  7. who do not want to purchase spectacles from AEH

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aravind Eye Hospital Madurai Tamil Nadu India

Sponsors and Collaborators

  • Johns Hopkins University
  • PlenOptika
  • Aravind Eye Care System

Investigators

  • Principal Investigator: David Friedman, MD, MPH, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT03615612
Other Study ID Numbers:
  • IRB00157754
First Posted:
Aug 6, 2018
Last Update Posted:
Jul 21, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2020