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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLDEB combined with GCV orally | Experimental | Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally. |
|
| GCV orally | Active Comparator | Ganciclovir (GCV) orally only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLDEB | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing time | Time to complete corneal epithelial healing | 14 ± 1 days |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal re-epithelization | Assessing complete corneal re-epithelization at day 14±1 using slit-lamp microcopy | 14 ± 1 days |
| Corneal opacity and vascularization | Assessing corneal opacity and vascularization using slit-lamp microcopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingfeng Zheng, M.D.Ph.D. | Contact | +8613922286455 | yingfeng.zheng@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity | Recruiting | Guangzhou | Guangdong | 5 | China |
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| ID | Term |
|---|---|
| D016849 | Keratitis, Herpetic |
| ID | Term |
|---|---|
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D006561 | Herpes Simplex |
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| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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|
|
| Ganciclovir (GCV) | Drug | Patient will be treated with GCV orally (200mg, 3 times a day, for 14 days). |
|
| Femtosecond laser | Device | A commercial femtosecond laser to create a particular shaped graft for transplantation. |
|
| Baseline, 14 ± 1 days, 3 months |
| Best-corrected visual acuity | Assessing best-corrected visual acuity using ETDRS chart | Baseline, 14 ± 1 days, 3 months |
| Corneal power and astigmatism | Assessing changes of corneal power and astigmatism using autorefractor keratometer | Baseline, 14 ± 1 days, 3 months |
| Corneal sensation | Assessing corneal sensation using Cochet-Bonnet esthesiometer | Baseline, 14 ± 1 days, 3 months |
| Recurrence | Assessing recurrent HSK using slit-lamp microcopy | 3 months |
| D006566 |
| Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |