An observational study in Neurotrophic Keratopathy, Exposure Keratopathy and Limbal Stem Cell Deficiency (LSCD), sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by IRCCS San Raffaele · Observational
This retrospective-prospective study aims to identify the diagnostic parameters most predictive of BSCVA in patients with OSD. Clinical, structural, and biochemical data will be collected from standard-of-care examinations and patient-reported outcome questionnaires. The goal is to determine the most informative biomarkers for visual prognosis, streamline diagnostic workflows, and support individualized management of OSD.
The study is based on the hypothesis that specific diagnostic parameters, reflecting corneal structure, ocular surface (including corneal nerve) integrity, inflammatory activity and patients' reported outcomes (questionnaires), can reliably predict BSCVA in patients with OSD. Identifying these predictors will enable evidence-based selection of diagnostic tests, streamline clinical workflows, and improve patient care efficiency.
This is a monocentric, national, retrospective-prospective, observational cohort study.
The design includes two complementary phases:
No experimental interventions or off-label diagnostic procedures are included; all assessments correspond to standard-of-care examinations.
Overall study duration: Approximately 60 months. Retrospective phase: a cohort of 1,500 patients will be selected among those patients who have been visited at the Cornea Clinic of the OSR in the last 20 years (starting from 01 Jan 2005 to 31 dec 2025) and who have a follow up of at least 12 months. Prospective phase: the investigators will enroll a cohort of 1,000 patients who will be rectruited among those visited at the Cornea Clinic of the OSR and who will be followed up for minimum 12 months. Recruitment will be ongoing for 48 months and the last patient will exit the study by month 60.
Individual patient duration: up to 12 months (baseline, 6-, and 12- month visits).
Interim analyses are planned at multiple time points throughout the study, contingent on data availability and sample size progression. The precise timing of these analyses will be determined based on the pace of data collection and event occurrence, rather than fixed calendar dates.
All data will be collected using standardized, validated diagnostic methods:
Retrospective data will be extracted from electronic medical records, while prospective data will be entered into a dedicated electronic case report form (eCRF) using harmonized acquisition protocols.
38 studies on the registry are indexed under Limbal Stem Cell Deficiency; 15 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 69 across 12 observational studies indexed under Limbal Stem Cell Deficiency.
Browse Limbal Stem Cell Deficiency studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
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The study will enroll adult patients (≥18 years old) of both sexes, representative of the population affected by OSD. No restrictions will be applied regarding ethnicity or socioeconomic background
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Best spectacle-corrected visual acuity (BSCVA) measured in logMAR
Best spectacle-corrected visual acuity will be measured using a standardized Early Treatment Diabetic Retinopathy Study chart at 4 meters after manifest refraction and best spectacle correction. Visual acuity will be reported as logarithm of the minimum angle of resolution. Expected range: -0.3 to 2.0 logMAR. Higher logMAR values indicate worse visual acuity.
Time frame: Baseline, 6, and 12 months
Maximum keratometry (K max) measured by corneal tomography
Maximum keratometry will be measured by corneal tomography. Unit of Measure is Diopters (D). Higher values indicate greater corneal steepening.
Time frame: Baseline, 6, and 12 months
Central corneal thickness (CCT) measured by corneal tomography
Central corneal thickness will be measured by corneal tomography. Unit of Measure is micrometers (µm). Lower values indicate greater corneal thinning.
Time frame: Baseline, 6, and 12 months
Corneal nerve density measured by in vivo confocal microscopy
Corneal nerve density will be measured using in vivo confocal microscopy. Unit of Measure is fibers/mm². Higher values indicate greater corneal nerve density.
Time frame: Baseline, 6, and 12 months
Corneal sensitivity measured by Cochet-Bonnet esthesiometer
Corneal sensitivity will be measured using the Cochet-Bonnet esthesiometer and reported as filament length. Unit of Measure is millimeter (mm). Higher values indicate better corneal sensitivity.
Time frame: Baseline, 6, and 12 months
Tear fluid interleukin-1 beta (IL-1β) concentration
Interleukin-1 beta concentration will be measured in tear fluid samples by tear film analysis. Unit of Measure is pg/mL. Higher values indicate greater inflammatory activity.
Time frame: Baseline, 6, and 12 months
Tear fluid interleukin-6 (IL-6) concentration
Interleukin-6 concentration will be measured in tear fluid samples by tear film analysis. Unit of Measure is pg/mL. Higher values indicate greater inflammatory activity.
Time frame: Baseline, 6, and 12 months
Tear fluid tumor necrosis factor-alpha (TNF-α) concentration
Tumor necrosis factor-alpha concentration will be measured in tear fluid samples by tear film analysis. Unit of Measure is pg/mL. Higher values indicate greater inflammatory activity.
Time frame: Baseline, 6, and 12 months
Tear fluid matrix metalloproteinase-9 (MMP-9) concentration
Matrix metalloproteinase-9 concentration will be measured in tear fluid samples by tear film analysis. Unit of Measure is ng/mL. Higher values indicate greater inflammatory activity.
Time frame: Baseline, 6, and 12 months
Inflammatory cell count measured by impression cytology
Inflammatory cell count will be measured using impression cytology of the ocular surface. Unit of Measure is cells/mm². Higher values indicate greater ocular surface inflammation.
Time frame: Baseline, 6, and 12 months
Intraocular pressure (IOP) measured by Goldmann applanation tonometry
Intraocular pressure will be measured using Goldmann applanation tonometry. Unit of Measure in mmHg. Higher values indicate higher intraocular pressure.
Time frame: Baseline, 6, and 12 months
Ocular Surface Disease Index (OSDI) score
Ocular surface symptoms and vision-related function will be assessed using the Ocular Surface Disease Index questionnaire. The total score ranges from 0 to 100, with higher scores indicating more severe ocular surface disease symptoms.
Time frame: Baseline, 6, and 12 months
Ocular Pain Assessment Survey (OPAS) quality-of-life interference score
Pain-related interference with quality of life will be assessed using the Ocular Pain Assessment Survey quality-of-life interference score. The score ranges from 0 to 10, where 0 indicates no interference with quality of life and 10 indicates maximum interference with quality of life. Higher scores indicate worse pain-related quality-of-life impairment.
Time frame: Baseline, 6, and 12 months
Visual Analog Scale (VAS) pain score
Ocular pain will be assessed using a Visual Analog Scale. The score ranges from 0 to 10, where 0 indicates no ocular pain and 10 indicates the worst imaginable ocular pain. Higher scores indicate worse ocular pain.
Time frame: Baseline, 6, and 12 months
National Eye Institute Visual Function Questionnaire-25 (VFQ-25) composite score
Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25. The composite score ranges from 0 to 100, where 0 indicates the worst possible vision-related quality of life and 100 indicates the best possible vision-related quality of life. Higher scores indicate better vision-related quality of life.
Time frame: Baseline, 6, and 12 months
Standard Patient Evaluation of Eye Dryness (SPEED) score
Dry eye symptoms will be assessed using the Standard Patient Evaluation of Eye Dryness questionnaire. The total score ranges from 0 to 28, where 0 indicates no dry eye symptoms and 28 indicates the most severe dry eye symptoms. Higher scores indicate worse dry eye symptoms.
Time frame: Baseline, 6, and 12 months
Plan to share: No
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Start is estimated for Jul 2026; primary completion for Dec 2029, 41 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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