Investigation of the Accuracy of an Automated Refractor to Provide Well-tolerated Eyeglass Prescriptions

July 29, 2025 updated by: Shivang R. Dave, PhD, PlenOptika, Inc.

Validation of the QuickSee Plus Device

At the New England College of Optometry in Boston, MA, subjects ages 18-65 who have received or are receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and automated refraction, by way of the QuickSee Plus refractor. Subjects will then be randomized into one of two treatment plans: receive glasses from automated refraction first then subjective refraction 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 triple blind, case-crossover clinical trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • New England College of Optometry (NECO) Center for Eye Care of Commonwealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • who have had an eye exam at the NECO Center for Eye Care of Commonwealth or Roslindale
  • who are aged between 18 years and 65 years

Exclusion Criteria:

  • whose refractive error is outside of the detection range of the QuickSee Free Pro and QuickSee Plus devices: -13 D to +10 D (S) and -8 D to + 8 D (C)
  • who are unable to provide consent
  • who have undergone any eye surgery
  • who have a history of ocular disease
  • who are taking systemic drugs
  • who wear more than one pair of single vision eyeglasses for distance
  • who more than occasionally wear soft contact lenses
  • who are unable and unwilling to wear the eyeglasses provided by the study for the required duration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AR Eyeglasses, then SR Eyeglasses
Automated Refraction (AR) Eyeglasses, then Subjective Refraction (SR) Eyeglasses
Other: AR Eyeglasses first, SR Eyeglasses second
First Eyeglasses based on Automated Refraction, Second Eyeglasses based on Subjective Refraction
Other: SR Eyeglasses, then AR Eyeglasses
Subjective Refraction (SR) Eyeglasses, then Automated Refraction (AR) Eyeglasses
Other: SR Eyeglasses first, AR Eyeglasses second
First Eyeglasses based on Subjective Refraction, Second Eyeglasses based on Automated Refraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Preference
Time Frame: 2 weeks
Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PlenOptika, Inc.

Collaborators

National Eye Institute (NEI)
New England College of Optometry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2025

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QuickSee Plus Trial
  • 2R44EY025452-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

March 2025 - May 2025

IPD Sharing Access Criteria

PlenOptika, New England College of Optometry, Data Safety Monitoring Board

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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