Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex Keratitis

NCT03217474 | Unknown

• 1 other identifier: 2017KYPJ052
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Herpes Simplex Keratitis

Outcome Measures

Primary Outcomes (1)

• Healing time

  Time to complete corneal epithelial healing

  14 ± 1 days

Secondary Outcomes (6)

• Corneal re-epithelization

  14 ± 1 days

• Corneal opacity and vascularization

  Baseline, 14 ± 1 days, 3 months

• Best-corrected visual acuity

  Baseline, 14 ± 1 days, 3 months

• Corneal power and astigmatism

  Baseline, 14 ± 1 days, 3 months

• Corneal sensation

  Baseline, 14 ± 1 days, 3 months

Study Arms (2)

FLDEB combined with GCV orally

EXPERIMENTAL

Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally.

Procedure: FLDEB; Drug: Ganciclovir (GCV); Device: Femtosecond laser

GCV orally

ACTIVE COMPARATOR

Ganciclovir (GCV) orally only

Drug: Ganciclovir (GCV)

Interventions

FLDEB PROCEDURE

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.

Also known as: Femtosecond laser-assisted corneal debridement

FLDEB combined with GCV orally

Ganciclovir (GCV) DRUG

Patient will be treated with GCV orally (200mg, 3 times a day, for 14 days).

FLDEB combined with GCV orally; GCV orally

Femtosecond laser DEVICE

A commercial femtosecond laser to create a particular shaped graft for transplantation.

FLDEB combined with GCV orally

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Platelet levels \< 150,000 or \> 450,000 per microliter;
• Hemoglobin \< 12.0 g/dL (male) or \< 11.0 g/dL (female);
• 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;
• Pregnancy (positive test) or lactation;
• Participation in another simultaneous medical investigation or clinical trial;

Sponsors & Collaborators

• Chunxiao Wang: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 5, China

RECRUITING

MeSH Terms

Conditions

Keratitis, Herpetic

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Keratitis; Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yizhi Liu, M.D.Ph.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Ting Huang, M.D.Ph.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingfeng Zheng, M.D.Ph.D.

CONTACT

+8613922286455; yingfeng.zheng@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical investigator

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: July 20, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2019
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

CN (1)