CClinicalTrials.gg
CompletedNCT03615612Updated Jul 21, 2020

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

An interventional study of QuickSee refractive error assessment + glasses in Refractive Errors, sponsored by Johns Hopkins University. Completed at 1 site in India. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-21.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2017, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Refractive Errors

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03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 400 is above the median of 82 across 296 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
400 participants (actual)

Study arms

  • Other
    OR Eyeglasses, then SR

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

    Other: QuickSee refractive error assessment + glasses

  • Other
    SR Eyeglasses, then OR

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

    Other: QuickSee refractive error assessment + glasses

Interventions

  • OtherQuickSee refractive error assessment + glasses

    QuickSee refractive error assessment + glasses

06

What researchers measure

Primary outcomes

  1. Patient Preference

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

    Time frame: 2 years

07

Study locations

1 site
  • Aravind Eye Hospital
    Madurai, Tamil Nadu, India
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03615612
Lead sponsor
Johns Hopkins University
Collaborators
PlenOptika, Aravind Eye Care System
Responsible party
Sponsor
First posted
Aug 6, 2018
Start date
Dec 15, 2017
Primary completion
Aug 2, 2019
Completion
Aug 30, 2019
Last update
Jul 21, 2020

Study contacts

David Friedman, MD, MPH, PhD
principal investigator · Johns Hopkins University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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