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

Not Applicable

Completed

• Conditions: Refractive Errors
• Interventions: Other: QuickSee refractive error assessment + glasses

• Registration Number: NCT03615612
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-15
• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-06
• Primary Completion: 2019-08-02
• Study Completion: 2019-08-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OR Eyeglasses, then SR	QuickSee refractive error assessment + glasses	Objective Refraction (OR) Eyeglasses, then Subjective Refraction (SR)
SR Eyeglasses, then OR	QuickSee refractive error assessment + glasses	Subjective Refraction (SR) Eyeglasses, then Objective Refraction (OR)

Primary Outcome Measures

Name	Time	Method
Patient Preference	2 years	Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Madurai, Tamil Nadu, India