Myopia
Conditions
Brief summary
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
Interventions
DEVICESoftware Trainer
Participants will receive the vision software trainer when randomized 1:1
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1st Outcome Measure | Baseline | 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: $$D\_{J0} = J\_{0,software} - J\_{0,unassisted}, \\quad D\_{J45} = J\_{45,software} - J\_{45,unassisted}$$. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measure | Baseline | Time-to-completion for software-guided vs. unassisted refraction |
Countries
United States
Outcome results
None listed