A Randomized Controlled Clinical Trial of Corneal Debridement for the Treatment of Herpes Simplex Epithelial Keratitis
Overview
- Phase
- Not Applicable
- Intervention
- FLDEB
- Conditions
- Herpes Simplex Keratitis
- Sponsor
- Chunxiao Wang
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Healing time
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of the study is to learn if adding femtosecond laser-assisted corneal debridement to a standard therapy of oral ganciclovir can help shorten the healing time of herpes simplex epithelial keratitis (HSK).
Investigators
Chunxiao Wang
Clinical investigator
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Aged between 18 and 80 years old;
- •Epithelial ulceration in a dendritic or geographic pattern, characteristic of infection with herpes simplex virus, and within 7 days of onset;
- •Ulcer's stromal involvement \< 120 micron, as indicated by anterior segment optical coherence tomography;
- •Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.
Exclusion Criteria
- •Clinical signs of a cause other than herpes simplex virus for the epithelial keratitis;
- •Antivirus or corticosteroid treatment within 6 months;
- •Active stromal keratitis or iritis;
- •History of allergy or adverse reaction to ganciclovir;
- •High myopia with a spherical equivalent of -15.0 D or less;
- •Corneal or ocular surface infection within 30 days prior to study entry;
- •Ocular surface malignancy;
- •Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
- •Renal failure with creatinine clearance\< 25ml/min;
- •Alanine aminotransferase \> 40IU/L, or aspartate aminotransferase \> 40IU/L;
Arms & Interventions
FLDEB combined with GCV orally
Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally.
Intervention: FLDEB
FLDEB combined with GCV orally
Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally.
Intervention: Ganciclovir (GCV)
FLDEB combined with GCV orally
Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally.
Intervention: Femtosecond laser
GCV orally
Ganciclovir (GCV) orally only
Intervention: Ganciclovir (GCV)
Outcomes
Primary Outcomes
Healing time
Time Frame: 14 ± 1 days
Time to complete corneal epithelial healing
Secondary Outcomes
- Corneal opacity and vascularization(Baseline, 14 ± 1 days, 3 months)
- Best-corrected visual acuity(Baseline, 14 ± 1 days, 3 months)
- Corneal sensation(Baseline, 14 ± 1 days, 3 months)
- Corneal re-epithelization(14 ± 1 days)
- Corneal power and astigmatism(Baseline, 14 ± 1 days, 3 months)
- Recurrence(3 months)