Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex Keratitis

A Randomized Controlled Clinical Trial of Corneal Debridement for the Treatment of Herpes Simplex Epithelial Keratitis

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).

Study Overview

• Status: Unknown
• Conditions: Herpes Simplex Keratitis
• Intervention / Treatment: Procedure: FLDEB; Drug: Ganciclovir (GCV); Device: Femtosecond laser

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 5
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged between 18 and 80 years old;
2. Epithelial ulceration in a dendritic or geographic pattern, characteristic of infection with herpes simplex virus, and within 7 days of onset;
3. Ulcer's stromal involvement < 120 micron, as indicated by anterior segment optical coherence tomography;
4. 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:

1. Clinical signs of a cause other than herpes simplex virus for the epithelial keratitis;
2. Antivirus or corticosteroid treatment within 6 months;
3. Active stromal keratitis or iritis;
4. History of allergy or adverse reaction to ganciclovir;
5. High myopia with a spherical equivalent of -15.0 D or less;
6. Corneal or ocular surface infection within 30 days prior to study entry;
7. Ocular surface malignancy;
8. Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
9. Renal failure with creatinine clearance< 25ml/min;
10. Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
11. Platelet levels < 150,000 or > 450,000 per microliter;
12. Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
13. Prothrombin time > 16s and activated partial thrombin time > 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy;
14. Pregnancy (positive test) or lactation;
15. Participation in another simultaneous medical investigation or clinical trial;
16. Severe cicatricial eye disease; Conjunctival scarring with fornix shortening;
17. Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
18. Any medical or social condition that in the judgement of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent;
19. Active immunological diseases;
20. History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FLDEB combined with GCV orally; Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally.	Procedure: FLDEB; The eye will be anesthetized, and femtosecond laser technology will be used to remove epithelial tissue (diameter: 8mm; depth: 100micron) that includes the loosened diseased corneal epithelial cells. Antibiotic ointments and drops will be instilled postoperatively.; Other Names: Femtosecond laser-assisted corneal debridement; Drug: Ganciclovir (GCV); Patient will be treated with GCV orally (200mg, 3 times a day, for 14 days).; Device: Femtosecond laser; A commercial femtosecond laser to create a particular shaped graft for transplantation.
ACTIVE_COMPARATOR: GCV orally; Ganciclovir (GCV) orally only	Drug: Ganciclovir (GCV); Patient will be treated with GCV orally (200mg, 3 times a day, for 14 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing time	Time to complete corneal epithelial healing	14 ± 1 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal re-epithelization	Assessing complete corneal re-epithelization at day 14±1 using slit-lamp microcopy	14 ± 1 days
Corneal opacity and vascularization	Assessing corneal opacity and vascularization using slit-lamp microcopy	Baseline, 14 ± 1 days, 3 months
Best-corrected visual acuity	Assessing best-corrected visual acuity using ETDRS chart	Baseline, 14 ± 1 days, 3 months
Corneal power and astigmatism	Assessing changes of corneal power and astigmatism using autorefractor keratometer	Baseline, 14 ± 1 days, 3 months
Corneal sensation	Assessing corneal sensation using Cochet-Bonnet esthesiometer	Baseline, 14 ± 1 days, 3 months
Recurrence	Assessing recurrent HSK using slit-lamp microcopy	3 months

Collaborators and Investigators

• Sponsor: Chunxiao Wang

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2017
• Primary Completion (ANTICIPATED): December 30, 2018
• Study Completion (ANTICIPATED): December 30, 2019

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (ACTUAL): July 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Eye Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Corneal Diseases; Herpesviridae Infections; Eye Infections; Eye Infections, Viral; Keratitis; Herpes Simplex; Keratitis, Herpetic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Ganciclovir; Ganciclovir triphosphate
• Other Study ID Numbers: 2017KYPJ052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No