WithdrawnNot Applicable

Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis

Stopped: No patient enrollment

United States0Started 2021-01-21

Plain-language summary

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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. The subject (male or female) is at least 18 years of age.
✓. The subject is presenting with primary or recurrent herpetic dendritic epithelial keratitis based on investigator judgement
✓. The subject is presenting with acute (within 30 days) herpetic dendritic epithelial keratitis
✓. The subject is willing to comply with all study procedures and is able to consent.

Exclusion criteria

✕. Clinical signs of a cause other than herpes simplex virus
✕. Presence of corneal ulcer with or without microbial infection
✕. Lid surface abnormalities or conjunctival scarring that affect lid function in either eye
✕. Atopic disease
✕. History of penetrating keratoplasty
✕. Active stromal keratitis or iritis
✕. 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)
✕. Ocular surface malignancy

What they're measuring

Time-dependent change in BCVA by 1 weeks

Timeframe: 1 week

Trial details

NCT IDNCT04598282

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10

View on ClinicalTrials.gov More Herpes Simplex Dendritic Keratitis trials