CTRI/2015/08/006147已完成1 期
A proof of concept study to evaluate the clinical safety and efficacy of a Poly Lactide-co-Glycolic Acid (PLGA) biodegradable, synthetic carrier membrane, used to regenerate epithelium using autologous limbal tissue as a single step procedure in patients having total unilateral limbal stem cell deficiency (LSCD). - LVPEI-2012-11
Wellcome Trust for Affordable Healthcare India R D0 个研究点目标入组 5 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male and female participants who are >=18 years of age.
- •2.Patients having a confirmed diagnosis of total LSCD as confirmed by any one or all of the following:
- •a.In-growth of conjunctival epithelium over the cornea (conjunctivalization),
- •b.360o absence of limbal Palisades of Vogt,
- •c.A fine stippled appearance on fluorescein staining,
- •d.Persistent or recurrent corneal epithelial defects
- •e.Superficial vascularization,
- •f.Dull and irregular corneal epithelium.
- •3.Participants having unilateral limbal stem cell deficiency due to chemical injury
- •4.No prior history of limbal transplantation
- •5.No ongoing and other active ocular pathology
- •6.No severe pathological and psychological conditions that might interfere with the patients participation in the study
- •7.Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice.
排除标准
- •1.Bilateral LSCD
- •2.LSCD due to autoimmune disorders and partial LSCD
- •3.Having other ongoing ocular pathologies and acute ocular inflammation
- •4.Previous neoplastic/cancer disease
- •5.Severe dry eyes confirmed by Schirmerâ??s test
- •6.Acute systemic infections
- •7.Prior history of limbal transplantation surgery or multiple surgeries in the limbal region
- •8.Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patientâ??s participation in the study or evaluation of the study results.
- •9. Any uncontrolled, inter-current illness that in the opinion of the Investigator may interfere with study evaluation.
- •10.Participants with uncontrolled diabetes will be excluded from the study
- •11.History or evidence of cardiac disease: congestive heart failure; New York Heart Association (NYHA) class 2 or greater (see Appendix 6); active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization.
- •12.Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
- •13.Reproductive age patients not practicing effective and adequate birth control measures
- •14.Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study.
- •15.Previous participation in this study
研究者
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