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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Placement of an Adjunctive Cryopreserved Amniotic Membrane Treatment.
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).
Casey Eye Institute, Oregon Health & Science University
Portland, Oregon, United States
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).
Time frame: 1 week
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)
Time frame: 1 week
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).
Time frame: 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).
Time frame: 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+.
Time frame: 2 months
Proportion of patients with recurrence by 2 months
Proportion of patients with recurrence by 2 months counted individually
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Time frame: 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.
Time frame: 2 months
Change in conjunctival inflammation at 1 week
Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3)
Time frame: 1 week
Change in conjunctival inflammation at 2 week
Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3)
Time frame: 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
Time frame: 2-3 months