Herpes Simplex Keratitis
Conditions
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).
Interventions
PROCEDUREFLDEB
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.
Patient will be treated with GCV orally (200mg, 3 times a day, for 14 days).
DEVICEFemtosecond laser
A commercial femtosecond laser to create a particular shaped graft for transplantation.
Sponsors
Chunxiao Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing time | 14 ± 1 days | Time to complete corneal epithelial healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal opacity and vascularization | Baseline, 14 ± 1 days, 3 months | Assessing corneal opacity and vascularization using slit-lamp microcopy |
| Best-corrected visual acuity | Baseline, 14 ± 1 days, 3 months | Assessing best-corrected visual acuity using ETDRS chart |
| Corneal re-epithelization | 14 ± 1 days | Assessing complete corneal re-epithelization at day 14±1 using slit-lamp microcopy |
| Corneal sensation | Baseline, 14 ± 1 days, 3 months | Assessing corneal sensation using Cochet-Bonnet esthesiometer |
| Recurrence | 3 months | Assessing recurrent HSK using slit-lamp microcopy |
| Corneal power and astigmatism | Baseline, 14 ± 1 days, 3 months | Assessing changes of corneal power and astigmatism using autorefractor keratometer |
Countries
China
Contacts
Primary ContactYingfeng Zheng, M.D.Ph.D.
Outcome results
None listed