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

NCT03615612 | Completed

• 1 other identifier: IRB00157754
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

• Patient Preference

  Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.

  2 years

Study Arms (2)

OR Eyeglasses, then SR

OTHER

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

Other: QuickSee refractive error assessment + glasses

SR Eyeglasses, then OR

OTHER

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

Other: QuickSee refractive error assessment + glasses

Interventions

QuickSee refractive error assessment + glasses OTHER

QuickSee refractive error assessment + glasses

OR Eyeglasses, then SR; SR Eyeglasses, then OR

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• PlenOptika, Inc.: collaborator
• Aravind Eye Care System: collaborator

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, India

Location

MeSH Terms

Conditions

Refractive Errors

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• David Friedman, MD, MPH, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: December 15, 2017
• Primary Completion: August 2, 2019
• Study Completion: August 30, 2019
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months
• Access Criteria: PlenOptika, Aravind Eye Hospital, Johns Hopkins

Locations

IN (1)