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| Name | Class |
|---|---|
| BioTissue Holdings, Inc | INDUSTRY |
| St. John's Hospital | OTHER |
| University of Colorado, Denver | OTHER |
The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects, visual recovery, refractive accuracy, and corneal clarity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProKera | Active Comparator |
| |
| Bandage contact lens | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProKera | Device | ProKera placed in non-dominant eye after photorefractive keratectomy (PRK) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days to Complete Re-epithelialization | measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy | participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain) | measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | Day 1 |
| Number of Eyes With Complications/Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard D Stutzman, MD | WRNMMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ProKera/Bandage Contact Lens | Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after photorefractive keratectomy (PRK) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ProKera and Bandage Contact Lens | Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK |
| 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 | Number of Days to Complete Re-epithelialization | measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy | Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK. For group 1, ProKera and bandage contact lens were left in place until complete corneal re-epithelialization (healing). | Posted | Mean | Standard Deviation | days to complete re-epithelialization | participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively | eyes | eyes |
|
1 year
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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 | ProKera | Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute non-granulomatous anterior uveitis | Eye disorders | Non-systematic Assessment | Acute, non-granulomatous anterior uveitis is a common, idiopathic inflammatory process that afflicts the iris and ciliary body. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir | 571-231-1600 | dha.belvoir.fbch.mbx.wresp-research@health.mil |
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| Bandage contact lens |
| Device |
Bandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK) |
|
| up to one year post-operatively |
| Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively | Uncorrected Distance Visual Acuity | one year post-operatively |
| Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively | Manifest spherical equivalent within +/- 0.50 diopters of emmetropia | one year post-operatively |
| Number of Eyes With Clinically Significant Corneal Haze | clinically significant corneal haze (grade 2 or higher) | one year postoperatively |
| Tear Total Protein Levels | total protein levels | 1 month post-operatively |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing) |
|
|
| Primary | Number of Days to Complete Re-epithelialization | measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy | Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 2, ProKera and bandage contact lens were left in place until postoperative day 3. | Posted | Mean | Standard Deviation | days to complete re-epithelialization | participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively | eyes | eyes |
|
|
|
| Primary | Number of Days to Complete Re-epithelialization | measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy | Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 3, ProKera and bandage contact lens were left in place until postoperative day 1. | Posted | Mean | Standard Deviation | days to complete re-epithelialization | participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively | eyes | eyes |
|
|
|
| Secondary | Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain) | measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | eyes | Posted | Mean | Standard Deviation | VAS score | Day 1 | eyes | eyes |
|
|
|
| Secondary | Number of Eyes With Complications/Adverse Events | eyes | Posted | Count of Units | eye | up to one year post-operatively | eye | eye |
|
|
|
| Secondary | Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively | Uncorrected Distance Visual Acuity | eyes | Posted | Count of Units | eyes | one year post-operatively | eyes | eyes |
|
|
|
| Secondary | Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively | Manifest spherical equivalent within +/- 0.50 diopters of emmetropia | eyes | Posted | Count of Units | eyes | one year post-operatively | eyes | eyes |
|
|
|
| Secondary | Number of Eyes With Clinically Significant Corneal Haze | clinically significant corneal haze (grade 2 or higher) | Posted | Count of Units | eyes | one year postoperatively | eyes | eyes |
|
|
|
| Secondary | Tear Total Protein Levels | total protein levels | samples | Posted | Mean | Standard Deviation | mg/ml | 1 month post-operatively | samples | samples |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 9 |
| 40 |
| EG001 | Bandage Contact Lens | Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK | 0 | 40 | 0 | 40 | 4 | 40 |
|
| Spontaneous extrusion of the graft (or BCL) at first postop week | Eye disorders | Non-systematic Assessment |
|
| Delayed epithelial healing in early postop | Eye disorders | Non-systematic Assessment |
|
| Persistent epithelial defect in early postop | Eye disorders | Non-systematic Assessment |
|
| corneal infiltrates (inflammatory) in early postop | Eye disorders | Non-systematic Assessment |
|
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| Persistent epithelial defect in early postop |
|
| Corneal infiltrates (inflammatory) in early postop |
|
| non-granulomatous anterior uveitis at 1 week postop |
|