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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-16

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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AR Eyeglasses, then SR Eyeglasses

Automated Refraction (AR) Eyeglasses, then Subjective Refraction (SR) Eyeglasses

Group Type OTHER

AR Eyeglasses first, SR Eyeglasses second

Intervention Type OTHER

First Eyeglasses based on Automated Refraction, Second Eyeglasses based on Subjective Refraction

SR Eyeglasses, then AR Eyeglasses

Subjective Refraction (SR) Eyeglasses, then Automated Refraction (AR) Eyeglasses

Group Type OTHER

SR Eyeglasses first, AR Eyeglasses second

Intervention Type OTHER

First Eyeglasses based on Subjective Refraction, Second Eyeglasses based on Automated Refraction

Interventions

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AR Eyeglasses first, SR Eyeglasses second

First Eyeglasses based on Automated Refraction, Second Eyeglasses based on Subjective Refraction

Intervention Type OTHER

SR Eyeglasses first, AR Eyeglasses second

First Eyeglasses based on Subjective Refraction, Second Eyeglasses based on Automated Refraction

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes