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Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex Keratitis

Sponsor
Chunxiao Wang (Other)
Overall Status
Unknown status
CT.gov ID
NCT03217474
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
29.3
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: FLDEB
  • Drug: Ganciclovir (GCV)
  • Device: Femtosecond laser
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Clinical Trial of Corneal Debridement for the Treatment of Herpes Simplex Epithelial Keratitis
Actual Study Start Date :
Jul 20, 2017
Anticipated Primary Completion Date :
Dec 30, 2018
Anticipated Study Completion Date :
Dec 30, 2019

Arms and Interventions

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).

    Outcome Measures

    Primary Outcome Measures

    1. Healing time [14 ± 1 days]

      Time to complete corneal epithelial healing

    Secondary Outcome Measures

    1. Corneal re-epithelization [14 ± 1 days]

      Assessing complete corneal re-epithelization at day 14±1 using slit-lamp microcopy

    2. Corneal opacity and vascularization [Baseline, 14 ± 1 days, 3 months]

      Assessing corneal opacity and vascularization using slit-lamp microcopy

    3. Best-corrected visual acuity [Baseline, 14 ± 1 days, 3 months]

      Assessing best-corrected visual acuity using ETDRS chart

    4. Corneal power and astigmatism [Baseline, 14 ± 1 days, 3 months]

      Assessing changes of corneal power and astigmatism using autorefractor keratometer

    5. Corneal sensation [Baseline, 14 ± 1 days, 3 months]

      Assessing corneal sensation using Cochet-Bonnet esthesiometer

    6. Recurrence [3 months]

      Assessing recurrent HSK using slit-lamp microcopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity Guangzhou Guangdong China 5

    Sponsors and Collaborators

    • Chunxiao Wang

    Investigators

    • Principal Investigator: 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chunxiao Wang, Clinical investigator, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03217474
    Other Study ID Numbers:
    • 2017KYPJ052
    First Posted:
    Jul 14, 2017
    Last Update Posted:
    Feb 22, 2018
    Last Verified:
    Feb 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Herpes Simplex
    Keratitis, Herpetic
    Keratitis
    Ganciclovir
    Ganciclovir triphosphate

    Study Results

    No Results Posted as of Feb 22, 2018