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Terminated due to low accrual
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To investigate whether the new applanation tonometer (EyeCheck monitor) can provide intraocular pressure (IOP) measurements comparable to those of traditional tonometers such as the Goldmann applanation tonometer and the Tonopen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EyeCheck | Experimental | EyeCheck pressures will be measured with contact lens in place |
|
| Traditional Tonometer (Goldmann and Tonopen) | Active Comparator | Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeCheck | Device | EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) Measurements | Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen) | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Asrani, MD | Duke Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
Currently, there is no plan to share data with other researchers.
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Each study participant was enrolled into both arms. Therefore 22 subjects were enrolled and had testing in each arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | EyeCheck and Traditional Tonometer (Goldmann and Tonopen) | EyeCheck pressures will be measured with contact lens in place EyeCheck: EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes. Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye). Traditional Tonometer (Goldmann and Tonopen): Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EyeCheck and Traditional Tonometer (Goldmann and Tonopen) | EyeCheck pressures will be measured with contact lens in place EyeCheck: EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes. Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye). Traditional Tonometer (Goldmann and Tonopen): Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck. |
| 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 | Intraocular Pressure (IOP) Measurements | Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen) | Participants received both EyeCheck and traditional tonometer measurements. | Posted | Mean | Full Range | mmHg | Baseline | eyes | eyes |
|
1 day
Each study participant was enrolled into both arms.
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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 | EyeCheck | EyeCheck pressures will be measured with contact lens in place EyeCheck: EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanjay Asrani | Duke Eye Center | +1 919 684 8656 | sanjay.asrani@duke.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 | Feb 9, 2022 | Sep 12, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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All subjects will first take their pressure using the EyeCheck with contact lens in and then remove their lens have pressures taken with Goldmann and Tonopen (two standard of care techniques of taking pressures of the eyes).
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| Traditional Tonometer (Goldmann and Tonopen) | Device | Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck. |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Traditional Tonometer (Goldmann and Tonopen) | Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye). Traditional Tonometer (Goldmann and Tonopen): Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck. | 0 | 22 | 0 | 22 | 0 | 22 |
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