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NCT Number: NCT07773753

Validation of the Vision Trainer Clinical Decision-Support Software

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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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennsylvania Presbyterian Hospital

Philadelphia, Pennsylvania, 19104, United States

Location contact

Chace Brokaw

CONTACT

215-662-9702

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Software Trainer

Device

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

Primary outcomes

  1. 1st Outcome Measure

    Time frame: 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

  1. Secondary Outcome Measure

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chace Brokaw, MS

CONTACT

[email protected]

8603389947

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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