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

PlenOptika, Inc.92 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Refractive Errors

Interventions

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

SR Eyeglasses first, AR Eyeglasses secondOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

New England College of Optometry (NECO) Center for Eye Care of Commonwealth

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Patient Preference

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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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