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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This study will evaluate the utility of TrueTear™ to improve anterior corneal surface imaging quality before cataract surgery, refractive lens exchange, or laser refractive surgery.
Corneal imaging will be repeated before and after TrueTear use during a single patient visit. Image quality measures will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TrueTear | Other | Use of TrueTear device to stimulate tear production |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueTear | Device | Ues of TrueTear neurostimulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surface Asymmetry Index (SAI) Assessed With Corneal Topography | Surface asymmetry index (SAI) is an index that indicates an average value of the corneal power differences between the points spatially located at 180° from 128 equidistant meridians. A radially symmetrical surface has a value of zero, and this value increases as the degree of asymmetry is greater. Higher values are worse, but there is no set maximum value and no unit of measure. | Change from baseline SAI at 5-10 minutes after using the TrueTear device. |
| Measure | Description | Time Frame |
|---|---|---|
| Surface Regularity Index (SRI) Assessed With Corneal Topography | Surface Regularity index (SRI) is a local descriptor of surface regularity in a central 4.5 mm diameter area of the cornea. It correlates well with the value of visual acuity (p = 0.80, P <0.001), assuming the cornea is the only limiting factor for vision. A normal cornea presents SRI values below 0.56 (the SRI would be 0 in a perfectly regular cornea). SRI values increase with increasing irregularity of the corneal surface. Higher values are worse, but there is no set maximum value and no unit of measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis W Price, Jr., MD | Price Vision Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TrueTear | Use of TrueTear device to stimulate tear production TrueTear: Use of TrueTear neurostimulator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TrueTear | Use of TrueTear device to stimulate tear production TrueTear: Ues of TrueTear neurostimulator |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Surface Asymmetry Index (SAI) Assessed With Corneal Topography | Surface asymmetry index (SAI) is an index that indicates an average value of the corneal power differences between the points spatially located at 180° from 128 equidistant meridians. A radially symmetrical surface has a value of zero, and this value increases as the degree of asymmetry is greater. Higher values are worse, but there is no set maximum value and no unit of measure. | Posted | Mean | Standard Deviation | unitless | Change from baseline SAI at 5-10 minutes after using the TrueTear device. |
|
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During the single study visit
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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 | TrueTear | Use of TrueTear device to stimulate tear production TrueTear: Ues of TrueTear neurostimulator |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne Price, PhD | Cornea Research Foundation of America | 3178142990 | mprice@cornea.org |
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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 28, 2018 | Aug 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| Change from baseline SRI at 5-10 minutes after using the TrueTear device. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
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| Participants |
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| Secondary | Surface Regularity Index (SRI) Assessed With Corneal Topography | Surface Regularity index (SRI) is a local descriptor of surface regularity in a central 4.5 mm diameter area of the cornea. It correlates well with the value of visual acuity (p = 0.80, P <0.001), assuming the cornea is the only limiting factor for vision. A normal cornea presents SRI values below 0.56 (the SRI would be 0 in a perfectly regular cornea). SRI values increase with increasing irregularity of the corneal surface. Higher values are worse, but there is no set maximum value and no unit of measure. | Posted | Mean | Standard Deviation | unitless | Change from baseline SRI at 5-10 minutes after using the TrueTear device. |
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| 0 |
| 45 |
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| 45 |
| 0 |
| 45 |
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