Validation of the Vision Trainer Clinical Decision-Support Software

NCT07773753 — Not applicable, Active not recruiting, 128 participants, University of Pennsylvania

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Validation of the Vision Trainer Clinical Decision-Support Software:A Randomized Comparison of Software-Guided Subjective Refraction(JCC and Non-JCC Algorithms) Against Unassisted Manual Refraction

Registry	NCT07773753
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: none, diagnostic
Enrollment	128 (Estimated)
Sponsor	University of Pennsylvania (Other)
Conditions	Myopia
Interventions	Software Trainer (Device)
Dates	start 2026-08-31, primary completion 2029-07-01 (estimated), completion 2030-09-01 (estimated), first posted 2026-08-19, last updated 2026-09-16
Locations	1 site in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Randomized 1:1	No intervention
Treatment Arm	Experimental	Device: Software Trainer	Receive the Vision Training Softward

Software Trainer (Device): Participants will receive the vision software trainer when randomized 1:1

+Outcome measures

Primary outcomes

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 outcomes

Secondary Outcome Measure [Baseline]: Time-to-completion for software-guided vs. unassisted refraction

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country	Status
Pennsylvania Presbyterian Hospital	Philadelphia, Pennsylvania	United States