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The purpose of this research is to determine if an investigational thin shield over the cornea can safely and effectively reduce or eliminate pain following Post Photorefractive Keratectomy (PRK).
The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.
See above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye shield | Experimental | Participants receive eye shield during PRK surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye Shield | Device | The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Uncorrected Visual Acuity | LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision | Six months |
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Inclusion criteria.
Exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Edward E Manche, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford | Palo Alto | California | 94303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30662255 | Result | Sales CS, Manche EE. Prospective evaluation of a novel silicone corneal shield after PRK: 6-month efficacy, safety, and predictability outcomes. Clin Ophthalmol. 2019 Jan 7;13:115-121. doi: 10.2147/OPTH.S183120. eCollection 2019. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eye Shield | Participants receive eye shield during PRK surgery Eye Shield: The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eye Shield | Participants receive eye shield during PRK surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain. | Posted | Count of Participants | Participants | Day 30 |
|
|
Six months
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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 | Eye Shield | Participants receive eye shield during PRK surgery | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward E. Manche | Stanford University School of Medcine | 6507255765 | edward.manche@stanford.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 | Aug 19, 2011 | Nov 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012030 | Refractive Errors |
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|
| Eyes |
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| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
|
|
| Secondary | Mean Change in Uncorrected Visual Acuity | LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision | Posted | Mean | Standard Deviation | logMAR | Six months | Eyes | Eyes |
|
|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D005128 | Eye Diseases |