NCT03217461已完成不适用
A Non-randomized Controlled Clinical Trial of Corneal Autograft for Limbal Dermoid
Chunxiao Wang1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年5月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Corneal Thickness
研究概览
简要总结
To investigate the clinical efficacy of femtosecond laser-assisted autologous lamellar keratoplasty in treating corneal dermoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 5 to 35 years old,
- •Patients with limbal dermoid, scheduled for elective surgical excision,
- •The distance of less than 5 mm of lesion encroachment into the cornea,
- •The participant or their legal guardian has voluntarily chosen to participate in this study, has signed the informed consent form, and has demonstrated a high level of adherence to the study protocols and cooperation throughout the follow-up process.
排除标准
- •Keratoconus,
- •High myopia with a spherical equivalent of -15.0 D or less,
- •Ocular and facial active inflammation such as keratitis, trachoma, dacryocystitis, blepharitis, meibomian gland dysfunction, Sjogren's syndrome, cicatricial pemphigoid etc,
- •Corneal or ocular surface infection within 30 days prior to study entry,
- •Severe cicatricial eye disease,
- •Ocular surface malignancy,
- •Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases,
- •History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries,
- •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 microlite,
- •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,
- •Active immunological diseases,
- •Signs of current infection, including fever and treatment with antibiotics,
- •Participation in another simultaneous medical investigation or clinical trial.
结局指标
主要结局
Corneal Thickness
时间窗: 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
To measure corneal thickness using anterior segment optical coherence tomography.
Corneal Transparency
时间窗: Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
The transparency and appearance of the cornea will be observed using slit-lamp microscopy
次要结局
- Best corrected visual acuity(Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively)
- Corneal power, astigmatism and aberration(Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively)
- Cosmetic improvement(Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively)
研究者
Chunxiao Wang
Clinical investigator
Sun Yat-sen University
研究点 (1)
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