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.
None
None
Patients diagnosed with corneal failure due to LSCD who accept and sign the informed written consent treatment to be treated with CLET
Cohort
Other
Not listed
Points of improvement in the Single Item Dry Eye Questionnaire (SIDEQ)
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)
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)
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)
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.
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Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Lead sponsor
Citospin
Collaborator
Red de Terapia Celular
Collaborator
University of Valladolid
Collaborator
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