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Lack of recruitment.
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The purpose of this study is to determine if short-term wear of a spherical rigid contact lens, called a scleral lens, will raise intraocular pressure in ocular hypertensive patients.
This is a randomized, self-controlled study designed to compare effectiveness of a scleral lens on intraocular pressure. In this study, all participants have one eye randomly selected to wear the scleral lenses during study measurements and the other eye serves as the control, non-lens wearing eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Eye | Experimental | One eye will be randomly selected to wear the scleral lenses to be worn during study measurements |
|
| Control Eye | No Intervention | Non-lens wearing eye |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scleral Lens | Device | 15.0 mm diagnostic spherical rigid contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | Intraocular pressure measured in millimeters of mercury (mm Hg) | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cherie Nau, OD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Eye | One eye will be randomly selected to wear the scleral lenses to be worn during study measurements Scleral Lens: 15.0 mm diagnostic spherical rigid contact lens |
| FG001 | Control Eye | Non-lens wearing eye |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants had one eye randomly selected to wear the scleral lenses during study measurements and the other eye served as the control, non-lens wearing eye. Scleral Lens: 15.0 mm diagnostic spherical rigid contact lens |
| 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) | Intraocular pressure measured in millimeters of mercury (mm Hg) | Posted | Number | mmHg | 4 hours | Eye | Eye |
|
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Adverse events were collected from baseline to end of study participation for a total of approximately 1 day on all participants.
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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 | Study Eye | One eye will be randomly selected to wear the scleral lenses to be worn during study measurements Scleral Lens: 15.0 mm diagnostic spherical rigid contact lens |
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Study terminated due to lack of recruitment and only one participant was enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cherie B. Nau, O.D. | Mayo Clinic | 507-284-4152 | Nau.Cherie@mayo.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 | Sep 1, 2018 | Mar 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Participants |
|
| 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 | Number | participants |
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| Participants |
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| Eye |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Control Eye | Non-lens wearing eye | 0 | 1 | 0 | 1 | 0 | 1 |
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