NCT03217474Unknown不适用
A Randomized Controlled Clinical Trial of Corneal Debridement for the Treatment of Herpes Simplex Epithelial Keratitis
Chunxiao Wang1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年7月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Healing time
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 80 years old;
- •Epithelial ulceration in a dendritic or geographic pattern, characteristic of infection with herpes simplex virus, and within 7 days of onset;
- •Ulcer's stromal involvement < 120 micron, as indicated by anterior segment optical coherence tomography;
- •Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.
排除标准
- •Clinical signs of a cause other than herpes simplex virus for the epithelial keratitis;
- •Antivirus or corticosteroid treatment within 6 months;
- •Active stromal keratitis or iritis;
- •History of allergy or adverse reaction to ganciclovir;
- •High myopia with a spherical equivalent of -15.0 D or less;
- •Corneal or ocular surface infection within 30 days prior to study entry;
- •Ocular surface malignancy;
- •Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
- •Renal failure with creatinine clearance< 25ml/min;
- •Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
- •Platelet levels < 150,000 or > 450,000 per microliter;
- •Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
- •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;
- •Pregnancy (positive test) or lactation;
- •Participation in another simultaneous medical investigation or clinical trial;
- •Severe cicatricial eye disease; Conjunctival scarring with fornix shortening;
- •Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
- •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;
- •Active immunological diseases;
- •History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
研究组 & 干预措施
FLDEB combined with GCV orally
Experimental
Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally.
干预措施: FLDEB (Procedure)
FLDEB combined with GCV orally
Experimental
Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally.
干预措施: Ganciclovir (GCV) (Drug)
FLDEB combined with GCV orally
Experimental
Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally.
干预措施: Femtosecond laser (Device)
GCV orally
Active Comparator
Ganciclovir (GCV) orally only
干预措施: Ganciclovir (GCV) (Drug)
结局指标
主要结局
Healing time
时间窗: 14 ± 1 days
Time to complete corneal epithelial healing
次要结局
- Corneal opacity and vascularization(Baseline, 14 ± 1 days, 3 months)
- Best-corrected visual acuity(Baseline, 14 ± 1 days, 3 months)
- Corneal sensation(Baseline, 14 ± 1 days, 3 months)
- Corneal re-epithelization(14 ± 1 days)
- Corneal power and astigmatism(Baseline, 14 ± 1 days, 3 months)
- Recurrence(3 months)
研究者
Chunxiao Wang
Clinical investigator
Sun Yat-sen University
研究点 (1)
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