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

Primary Purpose

Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
QuickSee refractive error assessment + glasses
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aravind Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

OR Eyeglasses, then SR

SR Eyeglasses, then OR

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 31, 2018
Last Updated
July 20, 2020
Sponsor
Johns Hopkins University
Collaborators
PlenOptika, Aravind Eye Care System
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1. Study Identification

Unique Protocol Identification Number
NCT03615612
Brief Title
Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions
Official Title
Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
PlenOptika, Aravind Eye Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OR Eyeglasses, then SR
Arm Type
Other
Arm Description
Objective Refraction (OR) Eyeglasses, then Subjective Refraction (SR)
Arm Title
SR Eyeglasses, then OR
Arm Type
Other
Arm Description
Subjective Refraction (SR) Eyeglasses, then Objective Refraction (OR)
Intervention Type
Other
Intervention Name(s)
QuickSee refractive error assessment + glasses
Intervention Description
QuickSee refractive error assessment + glasses
Primary Outcome Measure Information:
Title
Patient Preference
Description
Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants- who visit a Vision Center for their eye check-up who are aged between 18 years and 40 years Exclusion Criteria: Participants- whose refractive error is not within the detection range of the QuickSee device: -10 to +10 D who have a cylindrical power greater than 3 D who have to travel long distances (beyond 10kms) to the hospital who choose to buy spectacles that are priced more than Rs. 2000/- per pair who have speech or hearing impairment who do not speak the local language, Tamil who do not want to purchase spectacles from AEH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Friedman, MD, MPH, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aravind Eye Hospital
City
Madurai
State/Province
Tamil Nadu
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
PlenOptika, Aravind Eye Hospital, Johns Hopkins

Learn more about this trial

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

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