Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD): an Observational Study on Safety and Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Points of improvement about the Ocular Surface Disease Index (OSDI)
研究概览
简要总结
CLET is a published treatment for the management of corneal failure due to extensive LSCD. Due to our previous studies on this novel treatment, the regulatory agency of Spain "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" authorized our institution (IOBA-University of Valladolid) to perform this kind of therapy (CLET) in a case-by-case base following the Special Situation Medicines Policy Procedure in Spain. Upon approval of the permanent authorization patients will be included as specified by AEMPS.The objective of this study is to perform a protocolized treatment and follow up so that results can be reported to the scientific community.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Points of improvement about the Ocular Surface Disease Index (OSDI)
时间窗: 6 months
The OSDI evaluates ocular surface symptoms with 12 questions, and scores \>12 indicate abnormal symptomatology, and \>32 means severe symptoms (maximum score 100). One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.
Points of improvement in the National Eye Institute 25-item Visual Function Questionnaire (NEI-VFQ25)
时间窗: 6 months
The visual function-related aspects of the quality of life were evaluated with the NEI-VFQ25, where higher scores on a 0 to 100 scale indicate better function. One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.
Points of improvement in the Single Item Dry Eye Questionnaire (SIDEQ)
时间窗: 6 months
The SIDEQ gives a 0-4 score about the presence of dryness, foreign body sensation, burning/stinging, pain, itching, sensitivity to light, and blurred vision, where higher scores indicate higher intensity of the symptom (maximun score: 28). One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.
Points of improvement in the Change in Dry Eye Symptoms Questionnaire (CDES-Q)
时间窗: 6 months
The CDES-Q evaluates ocular surface symptoms with two questions, CDES-Q1 and CDES-Q2. CDES-Q1 evaluates the change in symptoms occured since the previous examination (same, better or worse). CDES-Q2 evaluates the magnitude of the change in a scale from 0 to 10, where 0 means "slightly better/worse" and 10 means "extremely better/worse". One of the primary outcomes for this work is the improvement in any of the four questionnaires shown here.
Percentage of improvement in corneal conjunctivalization
时间窗: 6 months
Percentage of corneal area with conjunctivalization (superficial opacity and/or superficial neovascularization) will be measured.
Complete absence of persistent epithelial defects
时间窗: 6 months
Corneal fluorescein staining has to rule out epithelial breakdown
次要结局
未报告次要终点