VisionApp - Ghosting

Assessment of the Accuracy and Repeatability of the VisionApp - Ghosting Measurement Protocol

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).

Study Overview

• Status: Recruiting
• Conditions: Diplopia, Monocular
• Intervention / Treatment: Device: Proclear 1 Day Contact Lens; Device: MyDay Contact Lens; Device: NaturalVue Contact Lens; Device: VisionApp; Device: MiSight 1 Day Contact Lens; Device: Investigational Contact Lens

Detailed Description

Subjects will be enrolled at the Clinical Optics Research Lab at Indiana University.

At the study visit, demographic and health/ocular history may be collected by oral history and standard clinical testing including refraction (check of glasses prescription), auto-refraction or abbrerometry may be performed. Visual acuity and room lighting checks may also be measured using standard clinical techniques.

For the experimental portion of the study visit, participants will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales, while wearing different contact lenses. Participants will first be asked to wear commercially available single vision contact lenses to establish best corrected vision. A single vision lens will then remain in one eye, and participants will proceed with ghosting assessments using two different multifocal contact lenses worn in the other eye. Adult participants will perform the ghosting assessments while wearing 2 commercially available multifocal lenses, and children participants will perform the ghosting assessments while wearing a commercially available and investigational lens. Randomization will determine which lens is worn first.

If participants are unable to complete all testing in a single session, they may be permitted to return on a subsequent day.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pete Kollbaum, PhD; Phone Number: 812-555-5500; Email: kollbaum@iu.edu

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Recruiting
      • Clinical Optics Research Lab
      • Contact: Pete Kollbaum, PhD; Email: kollbaum@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.; Device: 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.; Device: 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.; Device: 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.)
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.	Device: 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.; Device: 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.; Device: 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.; Device: 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.)
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.	Device: 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.; Device: 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.); Device: 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.; Device: 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.
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.	Device: 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.; Device: 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.); Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Diplopia; Equipment and Supplies; Optical Devices; Lenses; Contact Lenses
• Other Study ID Numbers: 12501b

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