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

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615612
• Other study ID #: IRB00157754
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: July 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 30, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractive Errors

Intervention

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

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Aravind Eye Care System, PlenOptika

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Preference	Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.	2 years