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VTI has an FDA cleared soft contact lens product. Its optical design creates an enhanced depth of focus (EDOF), which provides clear distance, intermediate, and near vision. This study is to quantify the enhanced depth of focus and visual impact.
This study will develop defocus curves for Baseline best corrected spectacle refraction and then for the EDOF lens used in this study. A comparison of thge depth of focus for each condition will be made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Presbyopia | Experimental | Subject's baseline vision will be compared with vision wearing treatment product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaturalVue Multifocal | Device | EDOF |
|
| Measure | Description | Time Frame |
|---|---|---|
| LogMAR Visual Acuity | High contrast/high illumination distant (6M) logMAR vision | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas P. Benoit, OD | Visioneering Technologies, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VTI | Alpharetta | Georgia | 30009 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39055378 | Derived | Tuan KA, Benoit DP, O'Connor B. Evaluation of the Functional Visual Range of a Catenary Curve-Based, Extended Depth-of-Focus Contact Lens for Presbyopia. Clin Ophthalmol. 2024 Jul 19;18:2113-2123. doi: 10.2147/OPTH.S468699. eCollection 2024. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Presbyopia | Subject's baseline vision will be compared with vision wearing treatment product NaturalVue Multifocal: EDOF |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Presbyopia | Subject's baseline vision will be compared with vision wearing treatment product NaturalVue Multifocal: EDOF |
| 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 | LogMAR Visual Acuity | High contrast/high illumination distant (6M) logMAR vision | Posted | Mean | Standard Deviation | logMAR | 4 hours |
|
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4 hours
Regular investigator assessment
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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 | Presbyopia | Subject's baseline vision will be compared with vision wearing treatment product NaturalVue Multifocal: EDOF |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Douglas P. Benoit | Visioneering Technologies, Inc. | 6035459507 | dbenoit@vtivision.com |
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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 | Jun 21, 2022 | Jun 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Subjects will serve as their own control using objective baseline data.
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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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| Visual acuity | logMAR visual acuity | Mean | Standard Deviation | logMAR |
|
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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