VisionApp - Refraction and Presbyopia

NCT07570602 | Completed FDA Device

• 1 other identifier: 12501a
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Recent Android mobile device technology is available which allows user-measured refractive error and reading add power. This technology could be quite useful to the clinical and research community. The current study aims to evaluate the accuracy, repeatability, and reproducibility of one such technology by VisionApp, specifically with regard to refraction and presbyopia. VisionApp is an app which runs on a smartphone or other device which uses the distance between the user's face and the phone to determine refractive error, while the user looks at different targets (lines, letters, words, etc).

Conditions

Presbyopia; Refractive Errors

Outcome Measures

Primary Outcomes (2)

• Spherical equivalent refractive error

  Spherical equivalent refractive error in diopters will be compared between Myopia Check and traditional refraction.

  Day 1

• Near presbyopic add

  Presbyopic near point in diopters as measured by the VisionApp technique and composite standard clinical measurements.

  Day 1

Study Arms (1)

Visual Assessment

EXPERIMENTAL

The subject will look at a phone running the VisionApp program set at a particular distance (calibration) and then be instructed to move further from, or closer to the phone, until a given target (letter, lines, patterns, etc) are more or less clear.

Device: VisionApp

Interventions

VisionApp DEVICE

VisionApp is an app which runs on a smartphone or other device which uses the distance between the user's face and the phone to determine refractive error, while the user looks at different targets (lines, letters, words, etc).

Visual Assessment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 40 years of age and currently wears a near add correction
• has a refractive error between Plano and -5.00 D of sphere and cylinder components combined.
• has best corrected visual acuity of at least 20/20 in each eye
• is not amblyopic or have any diagnosed ocular disease
• is willing and able to follow instructions and maintain the appointment schedule

You may not qualify if:

• has any systemic disease affecting ocular health and visual acuity
• is currently using any systemic or topical medications that could affect ocular health and visual acuity
• is participating in another eye related research study

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Clinical Optics Research Lab

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Presbyopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: July 5, 2023
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)