Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Patient Preference
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
OR Eyeglasses, then SR
Objective Refraction (OR) Eyeglasses, then Subjective Refraction (SR)
Intervention: QuickSee refractive error assessment + glasses (Other)
SR Eyeglasses, then OR
Subjective Refraction (SR) Eyeglasses, then Objective Refraction (OR)
Intervention: QuickSee refractive error assessment + glasses (Other)
Outcomes
Primary Outcomes
Patient Preference
Time Frame: 2 years
Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.
Secondary Outcomes
No secondary outcomes reported