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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Other: QuickSee refractive error assessment + glasses

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Madurai, Tamil Nadu, India
      • Aravind Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Preference	Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.	2 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Aravind Eye Care System; PlenOptika
• Investigators: Principal Investigator: David Friedman, MD, MPH, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: IRB00157754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 6 months
• IPD Sharing Access Criteria: PlenOptika, Aravind Eye Hospital, Johns Hopkins
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No