Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex Keratitis

Last updated: February 21, 2018
Sponsor: Chunxiao Wang
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT03217474
2017KYPJ052
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged between 18 and 80 years old;

  2. Epithelial ulceration in a dendritic or geographic pattern, characteristic ofinfection with herpes simplex virus, and within 7 days of onset;

  3. Ulcer's stromal involvement < 120 micron, as indicated by anterior segment opticalcoherence tomography;

  4. Informed consent signed by patient or legal guardian. Having the ability to complywith study assessments for the full duration of the study.

Exclusion

Exclusion Criteria:

  1. Clinical signs of a cause other than herpes simplex virus for the epithelialkeratitis;

  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 notaccepting anticoagulant therapy; An international normalized ratio greater than 3 inpatients 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 wouldinterfere with or serve as a contraindication to adherence to the study protocol orability to give informed consent;

  19. Active immunological diseases;

  20. History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucomafiltering surgeries.

Study Design

Total Participants: 100
Study Start date:
July 20, 2017
Estimated Completion Date:
December 30, 2019

Connect with a study center

  • Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

    Guangzhou, Guangdong 5
    China

    Active - Recruiting

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