Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex Keratitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-20

Study Completion Date

2019-12-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Herpes Simplex Keratitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FLDEB combined with GCV orally

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

Group Type EXPERIMENTAL

FLDEB

Intervention Type 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.

Ganciclovir (GCV)

Intervention Type DRUG

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

Femtosecond laser

Intervention Type DEVICE

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

GCV orally

Ganciclovir (GCV) orally only

Group Type ACTIVE_COMPARATOR

Ganciclovir (GCV)

Intervention Type DRUG

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

Interventions

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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.

Intervention Type PROCEDURE

Ganciclovir (GCV)

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

Intervention Type DRUG

Femtosecond laser

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

Intervention Type DEVICE

Other Intervention Names

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Femtosecond laser-assisted corneal debridement

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No