Purpose

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).

Condition

Eligibility

Eligible Ages
Over 8 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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: 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.
  • 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 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: 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.
  • 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.)

Recruiting Locations

Clinical Optics Research Lab
Bloomington, Indiana 47405
Contact:
Pete Kollbaum, PhD
kollbaum@iu.edu

More Details

Status
Recruiting
Sponsor
Indiana University

Study Contact

Pete Kollbaum, PhD
812-555-5500
kollbaum@iu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.