Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex Keratitis

Herpes Simplex Keratitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217474
• Other study ID #: 2017KYPJ052
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2017
• Last updated: February 21, 2018
• Start date: July 20, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2018
• Source: Sun Yat-sen University
• Contact: Yingfeng Zheng, M.D.Ph.D.
• Phone: +8613922286455
• Email: yingfeng.zheng[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Simplex Keratitis
• Keratitis
• Keratitis, Herpetic

Intervention

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.

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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chunxiao Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing time	Time to complete corneal epithelial healing	14 ± 1 days
Secondary	Corneal re-epithelization	Assessing complete corneal re-epithelization at day 14±1 using slit-lamp microcopy	14 ± 1 days
Secondary	Corneal opacity and vascularization	Assessing corneal opacity and vascularization using slit-lamp microcopy	Baseline, 14 ± 1 days, 3 months
Secondary	Best-corrected visual acuity	Assessing best-corrected visual acuity using ETDRS chart	Baseline, 14 ± 1 days, 3 months
Secondary	Corneal power and astigmatism	Assessing changes of corneal power and astigmatism using autorefractor keratometer	Baseline, 14 ± 1 days, 3 months
Secondary	Corneal sensation	Assessing corneal sensation using Cochet-Bonnet esthesiometer	Baseline, 14 ± 1 days, 3 months
Secondary	Recurrence	Assessing recurrent HSK using slit-lamp microcopy	3 months