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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03615612
Enrollment
400
Registered
2018-08-06
Start date
2017-12-15
Completion date
2019-08-30
Last updated
2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Errors

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.

Interventions

OTHERQuickSee refractive error assessment + glasses

QuickSee refractive error assessment + glasses

Sponsors

PlenOptika, Inc.
CollaboratorINDUSTRY
Aravind Eye Care System
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Preference2 yearsPatients are asked the question Which eyeglasses did you prefer?. Patient response is then recorded.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026