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No patient enrollment
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| Name | Class |
|---|---|
| BioTissue Holdings, Inc | INDUSTRY |
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To prospectively evaluate the effectiveness of Prokera Slim in adults with primary or recurrent herpetic epithelial keratitis in terms of visual function, corneal opacity, time to resolution, cost of care, number of patient visits.
Cryopreserved amniotic membrane (AM) contains anti-inflammatory, anti-scarring and antiangiogenic effects known in treating many ocular surface diseases. This notion is further strengthened by many studies showing that amniotic membrane can effectively control inflammation in HSV stromal keratitis in a murine model of HSV necrotizing keratitis and surgical application in ~7 human studies of epithelial and stromal HSV keratitis with or without an adjuvant antiviral therapy. More importantly, PROKERA SLIM in conjunction with oral acyclovir has been shown to facilitate the ease of early intervention to accelerate restoration in herpetic keratitis in 2 case series of 5 eyes. However, a formal prospective study has not been performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Placebo Comparator | All subjects enrolled in the study will receive the standard of care that includes epithelial debridement of all dendrites via Weck-Cel Cellulose sponge, topical prophylactic antibiotics (e.g., Ocuflox QID (four times daily) for one week) and oral acyclovir (400 mg 5x/day for 10 days for primary cases but tapered to 2x/day for 3 months for recurrent cases based on investigator's discretion). |
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| Treatment Arm | Active Comparator | All subjects enrolled in the study will receive the standard of care that includes epithelial debridement of all dendrites via Weck-Cel Cellulose sponge, topical prophylactic antibiotics (e.g., Ocuflox QID for one week) and oral acyclovir (400 mg 5x/day for 10 days for primary cases but tapered to 2x/day for 3 months for recurrent cases based on investigator's discretion). The treatment arm will also receive the placement of PROKERA SLIM for 5-7 days. A second PROKERA SLIM may be applied based on investigator's discretion. For patients with bilateral involvement only the worse eye will be enrolled for the treatment arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prokera Slim | Device | Placement of an Adjunctive Cryopreserved Amniotic Membrane Treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time-dependent change in BCVA by 1 weeks | The BSCVA was recorded at 4 meters by a refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL). | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with complete epithelialization by 1 week | Proportion of patients with complete epithelialization by 1 week, graded 0, SPK 1+, SPK 2+, SPK 3+ (SPK is Superficial Punctate Keratitis) | 1 week |
| Time-dependent change in BCVA by 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Stutzman, M.D. | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casey Eye Institute, Oregon Health & Science University | Portland | Oregon | 97239 | United States |
Share EPD once available
1 year
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| ID | Term |
|---|---|
| D007635 | Keratitis, Dendritic |
| ID | Term |
|---|---|
| D016849 | Keratitis, Herpetic |
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Standard of care includes epithelial debridement of all dendrites via Weck-Cel Cellulose sponge, topical prophylactic antibiotics (e.g., Ocuflox QID for one week) and oral acyclovir (400 mg 5x/day for 10 days for primary cases but tapered to 2x/day for 3 months for recurrent cases based on investigator's discretion). |
|
The BSCVA was recorded at 4 meters by a refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL). |
| 2 weeks |
| Time-dependent change in BCVA by 2 months | The BSCVA was recorded at 4 meters by a refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL). | 2 months |
| Proportion of patients with corneal opacity at 2 months | Proportion of patients with corneal opacity at 2 months, graded 0, 1+, 2+, 3+, and 4+. | 2 months |
| Proportion of patients with recurrence by 2 months | Proportion of patients with recurrence by 2 months counted individually | 2 months |
| Change in corneal sensitivity from baseline to 2 months | Change in corneal sensitivity from baseline to 2 months using Cochet-Bonnet esthesiometer, graded 0/4, 1/4, 2/4, 3/4, and 4/4. | 2 months |
| Change in conjunctival inflammation at 1 week | Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3) | 1 week |
| Change in conjunctival inflammation at 2 week | Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3) | 2 week |
| Total number of extra patient visits, treatments, and procedures throughout study | Total number of extra patient visits, treatments, and procedures throughout study, counted individually by type | 2-3 months |
| D006561 |
| Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |