NCT03217500Unknown不适用
A Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for Pterygium
Chunxiao Wang1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年7月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Restoration of corneal surface
研究概览
简要总结
The purpose of the study is to explore whether femtosecond laser-assisted cornea epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction after excision of pterygium.
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
- •Age between 18 to 80 years old;
- •Primary pterygium, scheduled for elective surgical excision;
- •Pterygium encroaching from the nasal side onto the cornea, with less than 180° limbal involvement and without approaching the central visual axis (pupil area);
- •Morphologically intact palisades of Vogt in a given limbal region;
- •Absence of any one of the following structures in the limbal region underneath the pterygium: (1) epithelial basal cells with dark cytoplasm and reflective cell borders; (2) at least two prominent palisade ridge structures; (3) at least one circular and/or oval-shaped focal stromal projection;
- •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
- •Limbal stem cell deficiency by ocular surface disorders other than pterygium;
- •Inability to determine whether the palisades of Vogt underneath the pterygium is absent or not using in vivo confocal microscopy;
- •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;
- •Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
- •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;
- •Signs of current infection, including fever and treatment with antibiotics;
- •Active immunological diseases;
- •History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
研究组 & 干预措施
Corneal epithelial autograft
Experimental
pterygium resection combined with femtosecond laser assisted corneal epithelial autograft
干预措施: Corneal epithelial autograft (Procedure)
Corneal epithelial autograft
Experimental
pterygium resection combined with femtosecond laser assisted corneal epithelial autograft
干预措施: Femtosecond laser (Device)
Limbal conjunctival autograft
Active Comparator
pterygium resection combined with diamond knife assisted limbal conjunctival autograft
干预措施: Limbal conjunctival autograft (Procedure)
Limbal conjunctival autograft
Active Comparator
pterygium resection combined with diamond knife assisted limbal conjunctival autograft
干预措施: Diamond knife (Device)
Simple removal
Active Comparator
Simple removal of pterygium
干预措施: Simple removal (Procedure)
结局指标
主要结局
Restoration of corneal surface
时间窗: 1 year
Restoration of a completely epithelized, stable, and avascular corneal surface
次要结局
- Reconstruction of palisades of Vogt(1 year)
- Corneal haze measurement(1 year)
- Recurrence of pterygium(1 year)
- Best corrected visual acuity(1 year)
- Corneal power and astigmatism(1 year)
研究者
Chunxiao Wang
Clinical investigator
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Corneal Epithelial Autograft for LSCDLimbal Stem Cell DeficiencyNCT03217487Chunxiao Wang20
已完成
不适用
Corneal Autograft for Limbal DermoidCorneal DermoidNCT03217461Chunxiao Wang19
已完成
不适用
Corneal Epithelial Allograft From Living-related Donor for LSCDLimbal Stem Cell DeficiencyNCT03217435Chunxiao Wang20
Unknown
不适用
Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex KeratitisHerpes Simplex KeratitisNCT03217474Chunxiao Wang100
已完成
4 期
Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract SurgeryCataractsNCT01383057Innovative Medical29