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

PlenOptika, Inc.

Status: Completed

Conditions: Refractive Errors

Treatments: Other: SR Eyeglasses first, AR Eyeglasses second; Other: AR Eyeglasses first, SR Eyeglasses second

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06883032

2R44EY025452-04 (U.S. NIH Grant/Contract)

QuickSee Plus Trial

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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92 participants in 2 patient groups

AR Eyeglasses, then SR Eyeglasses

Other group

Description:

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

Treatment:

Other: AR Eyeglasses first, SR Eyeglasses second

SR Eyeglasses, then AR Eyeglasses

Other group

Description:

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

Treatment:

Other: SR Eyeglasses first, AR Eyeglasses second