Herpes Simplex Dendritic Keratitis Clinical Trial
Official title:
A Pilot Study Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment for Primary or Recurrent Herpes Simplex Dendritic Keratitis
| Verified date | September 2022 |
| Source | Oregon Health and Science University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | July 28, 2022 |
| Est. primary completion date | October 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | Inclusion Criteria: 1. The subject (male or female) is at least 18 years of age. 2. The subject is presenting with primary or recurrent herpetic dendritic epithelial keratitis based on investigator judgement 3. The subject is presenting with acute (within 30 days) herpetic dendritic epithelial keratitis 4. The subject is willing to comply with all study procedures and is able to consent. Exclusion Criteria: 1. Clinical signs of a cause other than herpes simplex virus 2. Presence of corneal ulcer with or without microbial infection 3. Lid surface abnormalities or conjunctival scarring that affect lid function in either eye 4. Atopic disease 5. History of penetrating keratoplasty 6. Active stromal keratitis or iritis 7. Presence of systemic or ocular infection or inflammation that is not related to herpes simplex virus (such as Sarcoidosis, Cogan syndrome, atopy, Lyme disease, Syphilis, mumps, Epstein-Barr virus) 8. Ocular surface malignancy 9. History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK 10. A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial 11. Current enrollment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study 12. Not capable of providing informed consent |
| Country | Name | City | State |
|---|---|---|---|
| United States | Casey Eye Institute, Oregon Health & Science University | Portland | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| Oregon Health and Science University | Tissue Tech Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | Time-dependent change in BCVA by 2 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). | 2 weeks | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Proportion of patients with recurrence by 2 months | Proportion of patients with recurrence by 2 months counted individually | 2 months | |
| Secondary | 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 | |
| Secondary | Change in conjunctival inflammation at 1 week | Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3) | 1 week | |
| Secondary | Change in conjunctival inflammation at 2 week | Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3) | 2 week | |
| Secondary | 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 |