Validation of the Vision Trainer Clinical Decision-Support Software

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

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 Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Software Trainer

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chace Brokaw, MS; Phone Number: 8603389947; Email: chace.brokaw@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Pennsylvania Presbyterian Hospital
      • Contact: Chace Brokaw; Phone Number: 215-662-9702

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Randomized 1:1
Experimental: Treatment Arm; Receive the Vision Training Softward	Device: Software Trainer; Participants will receive the vision software trainer when randomized 1:1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: $$D_{J0} = J_{0,software} - J_{0,unassisted}, \quad D_{J45} = J_{45,software} - J_{45,unassisted}$$.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measure	Time-to-completion for software-guided vs. unassisted refraction	Baseline

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: July 31, 2026
• First Submitted That Met QC Criteria: August 16, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 26-7073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No