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OpenTrials
Completed

NCT Number: NCT03615612

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

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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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aravind Eye Hospital

Madurai, Tamil Nadu, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QuickSee refractive error assessment + glasses

Other

QuickSee refractive error assessment + glasses

Primary outcomes

  1. Patient Preference

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Aravind Eye Care System
  • PlenOptika, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 6, 2018
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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