An observational study in Limbal Stem-cell Deficiency, sponsored by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA. Not yet recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Observational
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.
40 studies on the registry are indexed under Limbal Stem Cell Deficiency; 15 are open to participants now.
This study's planned enrollment of 30 is below the median of 69 across 12 observational studies indexed under Limbal Stem Cell Deficiency.
Browse Limbal Stem Cell Deficiency studies →Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with corneal failure due to LSCD who accept and sign the informed written consent treatment to be treated with CLET
Total and/or severe LSCD of any etiology in one or both eyes.
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)
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
Percentage of improvement in corneal conjunctivalization
Percentage of corneal area with conjunctivalization (superficial opacity and/or superficial neovascularization) will be measured.
Time frame: 6 months
Complete absence of persistent epithelial defects
Corneal fluorescein staining has to rule out epithelial breakdown
Time frame: 6 months
Plan to share: No
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA