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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2019-08-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OR Eyeglasses, then SR

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

Group Type OTHER

QuickSee refractive error assessment + glasses

Intervention Type OTHER

QuickSee refractive error assessment + glasses

SR Eyeglasses, then OR

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

Group Type OTHER

QuickSee refractive error assessment + glasses

Intervention Type OTHER

QuickSee refractive error assessment + glasses

Interventions

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QuickSee refractive error assessment + glasses

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. who visit a Vision Center for their eye check-up
2. who are aged between 18 years and 40 years

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes