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

Johns Hopkins University

Status: Completed

Conditions: Refractive Errors

Treatments: Other: QuickSee refractive error assessment + glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT03615612

IRB00157754

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups

OR Eyeglasses, then SR

Other group

Description:

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

Treatment:

Other: QuickSee refractive error assessment + glasses

SR Eyeglasses, then OR

Other group

Description:

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

Treatment:

Other: QuickSee refractive error assessment + glasses