NCT07571538

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 ghosting vision. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Oct 2025Aug 2026

Study Start

First participant enrolled

October 10, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ghosting Quantification

    Ghosting quantification (e.g. how "doubled" the image looks) will be compared against expected template images and those predicted. Subjects will provide a quality rating of ghosting on a scale between 0 - 100, with lower scores indicating more ghosting of the image and 100 representing an optically perfect image. The VisionApp will also model ghosting measurements for direction, separation, blur and strength into a predictive quality rating, which will be compared to the subject's subjective expected, or overall, quality rating.

    Day 1

Study Arms (4)

Adults: Lens 1, then Lens 2

ACTIVE COMPARATOR

Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.

Device: Proclear 1 Day Contact LensDevice: MyDay Contact LensDevice: NaturalVue Contact LensDevice: VisionApp

Adults: Lens 2, then Lens 1

ACTIVE COMPARATOR

Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.

Device: Proclear 1 Day Contact LensDevice: MyDay Contact LensDevice: NaturalVue Contact LensDevice: VisionApp

Children: Lens 3, then Lens 4

ACTIVE COMPARATOR

Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.

Device: Proclear 1 Day Contact LensDevice: MiSight 1 Day Contact LensDevice: MiSight ABC Contact LensDevice: VisionApp

Children: Lens 4, then Lens 3

ACTIVE COMPARATOR

Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.

Device: Proclear 1 Day Contact LensDevice: MiSight 1 Day Contact LensDevice: MiSight ABC Contact LensDevice: VisionApp

Interventions

Proclear 1 day is a commercially available single vision soft contact lens for single use (daily wear). Participants will wear these contacts at the beginning of the study visit to establish best corrected vision. Participants will then continue to wear this contact lens in one eye for the duration of the study visit.

Adults: Lens 1, then Lens 2Adults: Lens 2, then Lens 1Children: Lens 3, then Lens 4Children: Lens 4, then Lens 3

MyDay is a commercially available multifocal soft contact lens for daily wear. Adult participants will assess images for ghosting while wearing a MyDay contact lens in one eye. Order of exposure to this lens will be determined via randomization.

Adults: Lens 1, then Lens 2Adults: Lens 2, then Lens 1

MiSight ABC is an investigational multifocal soft contact lens for daily wear. While the contact lens is made of an FDA approved material which is already marketed in the United States, it differs from commercially available lenses in that it has a slightly different optical design.Children participants will assess images for ghosting while wearing a MiSight ABC contact lens in one eye. Order of exposure to this lens will be determined via randomization.

Children: Lens 3, then Lens 4Children: Lens 4, then Lens 3
VisionAppDEVICE

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.)

Adults: Lens 1, then Lens 2Adults: Lens 2, then Lens 1Children: Lens 3, then Lens 4Children: Lens 4, then Lens 3

NaturalVue is a commercially available multifocal soft contact lens for daily wear. Adult participants will assess images for ghosting while wearing a NaturalVue contact lens in one eye. Order of exposure to this lens will be determined via randomization.

Adults: Lens 1, then Lens 2Adults: Lens 2, then Lens 1

MiSight 1 Day is a commercially available multifocal soft contact lens for daily wear. Children participants will assess images for ghosting while wearing a MiSight 1 Day contact lens in one eye. Order of exposure to this lens will be determined via randomization.

Children: Lens 3, then Lens 4Children: Lens 4, then Lens 3

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • has a refractive error between Plano and -5.00 D of sphere and cylinder components combined.
  • has refractive cylinder (e.g., astigmatism) of -0.75 D or less
  • has had a self-reported oculo-visual exam in the last 2 years
  • has best-corrected visual acuity of at least 20/20 in each eye
  • is not amblyopic or does not 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Optics Research Lab

Bloomington, Indiana, 47405, United States

RECRUITING

MeSH Terms

Conditions

Diplopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Central Study Contacts

Pete Kollbaum, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
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

October 10, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations