Validation of the Vision Trainer Clinical Decision-Support Software

ConditionMyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Software Trainer

Treatment groups

128 Participants
are divided into 2 treatment groups

Sponsors and collaborators