Recruiting

VisionApp

Sponsor:

Indiana University

Code:

NCT07571538

Conditions

Diplopia, Monocular

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

Interventions

Proclear 1 Day Contact Lens

MyDay Contact Lens

NaturalVue Contact Lens

MiSight 1 Day Contact Lens

Investigational Contact Lens

Study Details

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).

Conditions

Diplopia, Monocular

Study ID

NCT07571538

Start date

Oct 10, 2025

Status verified date

Aug, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Adults: Lens 1, then Lens 2

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.

active comparator: Adults: Lens 2, then Lens 1

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.

active comparator: Children: Lens 3, then Lens 4

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.

active comparator: Children: Lens 4, then Lens 3

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.

Interventions

Proclear 1 Day Contact Lens

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.

MyDay Contact Lens

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.

NaturalVue Contact Lens

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.

MiSight 1 Day Contact Lens

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.

Investigational Contact Lens

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 this investigational contact lens in one eye. Order of exposure to this lens will be determined via randomization.

VisionApp

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.)

Primary outcome measure

  • Ghosting Quantification [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Pete Kollbaum, PhD

812-555-5500kollbaum@iu.edu

Locations

Clinical Optics Research Lab

Recruiting

Bloomington, Indiana, United States, 47405

Contacts

Pete Kollbaum, PhD

kollbaum@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-24.