Diplopia, MonocularNCT07571538
VisionApp - Ghosting
A study testing Proclear 1 Day Contact Lens, MyDay Contact Lens and NaturalVue Contact Lens in people with Diplopia, Monocular, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diplopia, Monocular
- What is being tested?
- Proclear 1 Day Contact Lens, MyDay Contact Lens and NaturalVue Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Optics Research Lab
Bloomington, Indiana, 47405
Pete Kollbaum, PhD, kollbaum@iu.edu
About this study
Official title: 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).
Read the 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.
- Conditions
- Diplopia, Monocular
- Being tested
- Proclear 1 Day Contact Lens, MyDay Contact Lens, NaturalVue Contact Lens, MiSight 1 Day Contact Lens, Investigational Contact Lens
- Medical subject headings
- Diplopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proclear 1 Day Contact LensDevice
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 LensDevice
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 LensDevice
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 LensDevice
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 LensDevice
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.
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Proclear 1 Day Contact Lens; Device: MyDay Contact Lens; Device: NaturalVue Contact Lens; Device: 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. Receives: Device: Proclear 1 Day Contact Lens; Device: MyDay Contact Lens; Device: NaturalVue Contact Lens; Device: 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. Receives: Device: Proclear 1 Day Contact Lens; Device: MiSight 1 Day Contact Lens; Device: Investigational Contact Lens; Device: 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. Receives: Device: Proclear 1 Day Contact Lens; Device: MiSight 1 Day Contact Lens; Device: Investigational Contact Lens; Device: VisionApp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start10 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplopia, MonocularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pete Kollbaum, OD, PhD, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571538
- Sponsor's protocol ID
- 12501b
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy and Repeatability of the VisionApp - Ghosting Measurement Protocol
- ClinicalTrials.gov ID
- NCT07571538
- Acronym / sponsor ID
- 12501b
- Conditions
- Diplopia, Monocular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adults: Lens 1, then Lens 2 | Active comparator | Device: Proclear 1 Day Contact Lens, Device: MyDay Contact Lens, Device: NaturalVue Contact Lens, Device: VisionAppSubjects 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. |
| Adults: Lens 2, then Lens 1 | Active comparator | Device: Proclear 1 Day Contact Lens, Device: MyDay Contact Lens, Device: NaturalVue Contact Lens, Device: VisionAppSubjects 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. |
| Children: Lens 3, then Lens 4 | Active comparator | Device: Proclear 1 Day Contact Lens, Device: MiSight 1 Day Contact Lens, Device: Investigational Contact Lens, Device: VisionAppSubjects 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. |
| Children: Lens 4, then Lens 3 | Active comparator | Device: Proclear 1 Day Contact Lens, Device: MiSight 1 Day Contact Lens, Device: Investigational Contact Lens, Device: VisionAppSubjects 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proclear 1 Day Contact LensProclear 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 | Adults: Lens 1, then Lens 2, Adults: Lens 2, then Lens 1, Children: Lens 3, then Lens 4, Children: Lens 4, then Lens 3 |
| MyDay Contact LensMyDay 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 | Adults: Lens 1, then Lens 2, Adults: Lens 2, then Lens 1 |
| NaturalVue Contact LensNaturalVue 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 | Adults: Lens 1, then Lens 2, Adults: Lens 2, then Lens 1 |
| MiSight 1 Day Contact LensMiSight 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 | Children: Lens 3, then Lens 4, Children: Lens 4, then Lens 3 |
| Investigational Contact LensAn 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 | Children: Lens 3, then Lens 4, Children: Lens 4, then Lens 3 |
| VisionAppVisionApp 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 | Adults: Lens 1, then Lens 2, Adults: Lens 2, then Lens 1, Children: Lens 3, then Lens 4, Children: Lens 4, then Lens 3 |
Primary outcome
Ghosting Quantification
Time frame: Day 1
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proclear 1 Day Contact Lens, MyDay Contact Lens and NaturalVue Contact Lens in people with Diplopia, Monocular, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pete Kollbaum, PhD (812-555-5500, kollbaum@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ghosting Quantification (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.