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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VisionApp | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Spherical Equivalent Refractive Error | Spherical equivalent refractive error in diopters will be compared between Myopia Check and traditional refraction. | Day 1 |
| Near Presbyopic Add | Presbyopic near point in diopters as measured by the VisionApp technique and composite standard clinical measurements. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optics Research Lab | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Visual Assessment | 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. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Visual Assessment | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spherical Equivalent Refractive Error | Spherical equivalent refractive error in diopters will be compared between Myopia Check and traditional refraction. | Posted | Mean | Standard Deviation | diopters | Day 1 |
|
Participants were monitored/assessed for adverse events during the study, up to 1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Visual Assessment | 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. 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pete Kollbaum | IU School of Optometry - Clinical Optics Research Lab | 812-856-0108 | kollbaum@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2021 | May 6, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Primary | Near Presbyopic Add | Presbyopic near point in diopters as measured by the VisionApp technique and composite standard clinical measurements. | Posted | Mean | Standard Deviation | diopters | Day 1 |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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