Validation of the Vision Trainer Clinical Decision-Support Software

N/AActive Not RecruitingNCT07773753

University of Pennsylvania128 enrolled

Overview

This study is a prospective, randomized, crossover clinical investigation designed to evaluate the accuracy, efficiency, and usability of the Vision Trainer software for subjective refraction. The study compares software-guided refraction, implemented using both Jackson Cross Cylinder (JCC) and Non-JCC workflows, against standard unassisted manual refraction performed by trained examiners

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

128

Conditions

Myopia

Interventions

Software TrainerDEVICE

Participants will receive the vision software trainer when randomized 1:1

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of signed and dated informed consent form prior to any study procedures. * Age ≥18 years at the time of informed consent. * Best corrected visual acuity (BCVA) of at least 20/40 in both eyes, measured with current spectacle or contact lens correction. * Able to provide informed consent in English. * Willing and able to complete an approximately 25-30-minute study visit * No significant ocular pathology or media opacity that would preclude accurate standard refraction. Exclusion Criteria: * Ocular pathology significantly affecting visual function: untreated or advanced glaucoma, advanced age-related macular degeneration, proliferative diabetic retinopathy with vision loss, current retinal detachment, or other posterior segment disease materially impairing BCVA. * Recent ocular surgery within the prior 6 months, including refractive surgery (LASIK, PRK, SMILE, phakic IOL), cataract surgery, or other intraocular procedures. * Spherical equivalent refractive error exceeding ±12 Diopters. * Any medical condition or circumstance that, in the judgment of the Investigator, would preclude safe or valid participation.

Locations (1)

Pennsylvania Presbyterian Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

1st Outcome Measure

To demonstrate non-inferiority of Vision Trainer software-guided refraction (JCC and Non-JCC workflows combined) versus unassisted standard manual refraction in terms of prescription accuracy. Two co-primary effectiveness endpoints are defined at the eye level. The first endpoint is the signed difference in Mean Spherical Equivalent (MSE), calculated as $$D\_{MSE} = \\text{MSE}\_{software} - \\text{MSE}\_{unassisted}$$. The second endpoint is astigmatic component accuracy, computed as signed Thibos power-vector component differences: $$D\_{J0} = J\_{0,software} - J\_{0,unassisted}, \\quad D\_{J45} = J\_{45,software} - J\_{45,unassisted}$$.

Time frame: Baseline

Secondary Outcomes

Secondary Outcome Measure

Time-to-completion for software-guided vs. unassisted refraction

Time frame: Baseline

Data from ClinicalTrials.gov

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