Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD) (CLET-4-LSCD)
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|ClinicalTrials.gov Identifier: NCT03884569|
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
|Condition or disease|
|Limbal Stem-cell Deficiency|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD): an Observational Study on Safety and Effectiveness|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Patients treated with CLET
Previously treated with CLET patients are included retrospectively, as the follow-up procedure is already stablished in our centre, and patients treated following standard care or through "drugs-in-special-situation" request in Spain prospectively. Patients are not treated to be included in the study, only the follow-up variables are taken into account.
- Points of improvement in the Single Item Dry Eye Questionnaire (SIDEQ) [ Time Frame: 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 about the Ocular Surface Disease Index (OSDI) [ Time Frame: 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) [ Time Frame: 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 Change in Dry Eye Symptoms Questionnaire (CDES-Q) [ Time Frame: 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 [ Time Frame: 6 months ]Percentage of corneal area with conjunctivalization (superficial opacity and/or superficial neovascularization) will be measured.
- Complete absence of persistent epithelial defects [ Time Frame: 6 months ]Corneal fluorescein staining has to rule out epithelial breakdown
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884569
|Contact: Margarita Calonge, MD, PhDfirstname.lastname@example.org|
|Valladolid, Spain, 47011|
|Contact: Margarita Calonge, MD, PhD|
|Principal Investigator: Margarita Calonge, MD, PhD|