PresbyopiaNCT07570602
VisionApp - Refraction and Presbyopia
A study testing VisionApp in people with Presbyopia and Refractive Errors, 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 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Refractive Errors
- What is being tested?
- VisionApp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 40 years of age and currently wears a near add correction
- has a refractive error between Plano and -5.00 D of sphere and cylinder components combined.
- has best corrected visual acuity of at least 20/20 in each eye
- is not amblyopic or 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.
United States1 site
Clinical Optics Research Lab
Bloomington, Indiana, 47405
About this study
Official title: Assessment of the Accuracy and Repeatability of the VisionApp - Refraction and Presbyopia 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 refraction and presbyopia.
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 and complete a single study visit.
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 aberrometry 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, the subject will look at a phone running the VisionApp program set at a particular distance (calibration) and then be instructed to move further from, or closer to the phone, until a given target (letter, lines, patterns, etc) are more or less clear. Each test may be repeated until at least 10 good data points are collected. This may be done on the right eye, left eye, or both eyes.
- Conditions
- Presbyopia, Refractive Errors
- Being tested
- VisionApp
- Medical subject headings
- Presbyopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 |
|---|---|---|
| Visual Assessment | Experimental | The subject will look at a phone running the VisionApp program set at a particular distance (calibration) and then be instructed to move further from, or closer to the phone, until a given target (letter, lines, patterns, etc) are more or less clear. Receives: Device: VisionApp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical Equivalent Refractive Error
Spherical equivalent refractive error in diopters will be compared between Myopia Check and traditional refraction.
Measured: Day 1
Near Presbyopic Add
Presbyopic near point in diopters as measured by the VisionApp technique and composite standard clinical measurements.
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 start5 Jul 2023
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
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
- NCT07570602
- Sponsor's protocol ID
- 12501a
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Jun 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 - Refraction and Presbyopia Measurement Protocol
- ClinicalTrials.gov ID
- NCT07570602
- Acronym / sponsor ID
- 12501a
- Conditions
- Presbyopia, Refractive Errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Posted 11 Jun 2026
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 refraction and presbyopia.
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 and complete a single study visit.
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 aberrometry 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, the subject will look at a phone running the VisionApp program set at a particular distance (calibration) and then be instructed to move further from, or closer to the phone, until a given target (letter, lines, patterns, etc) are more or less clear. Each test may be repeated until at least 10 good data points are collected. This may be done on the right eye, left eye, or both eyes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual Assessment | Experimental | Device: VisionAppThe subject will look at a phone running the VisionApp program set at a particular distance (calibration) and then be instructed to move further from, or closer to the phone, until a given target (letter, lines, patterns, etc) are more or less clear. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 40 years of age and currently wears a near add correction
- has a refractive error between Plano and -5.00 D of sphere and cylinder components combined.
- has best corrected visual acuity of at least 20/20 in each eye
- is not amblyopic or have any diagnosed ocular disease
- is willing and able to follow instructions and maintain the appointment schedule
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 |
|---|---|---|
| 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 | Visual Assessment |
Primary outcome
Spherical Equivalent Refractive Error
Time frame: Day 1
Spherical equivalent refractive error in diopters will be compared between Myopia Check and traditional refraction.
Near Presbyopic Add
Time frame: Day 1
Presbyopic near point in diopters as measured by the VisionApp technique and composite standard clinical measurements.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisionApp in people with Presbyopia and Refractive Errors, 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 5 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: finished, as of the sponsor's last update on 11 Jun 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?
Yes. Results are posted in the registry (first posted 11 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical Equivalent Refractive Error (time frame: Day 1). The study lists 2 primary outcomes in all. 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 11 Jun 2026.