Ensaio clínico em Ceratopatia Neurotrófica, Doença da Córnea, Deficiência de células-tronco do limbo (LSCD), Córnea Inflamada, Anormalidade da córnea, Exposure Keratopathy - Registro de Ensaios Clínicos

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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:

Retrospective cohort (n = 1,500): existing clinical records will be reviewed to extract standardized diagnostic and visual acuity data.
Prospective cohort (n = 1,000): newly enrolled patients will undergo a standardized diagnostic protocol and follow-up vists at defined time points.

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:

Corneal topography (maximum keratometry, Kmax) and pachymetry
In vivo confocal microscopy (corneal nerve density and cellular morphology)
Slit-lamp photography (conjunctival hyperemia and corneal opacity grading)
Cochet-Bonnet esthesiometer (corneal sensitivity)
Goldmann applanation tonometry (intraocular pressure)
Tear cytokine quantification (including IL-1β, IL-6, TNF-α, MMP-9, multiplex immunoassay)
Impression cytology (inflammatory cell counts)
Ocular pain/quality of life questionnaire scores (OSDI, OPAS, VAS, VFQ25, SPEED)

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

1000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Giulio Ferrari, MD, PhD, Professor
Número de telefone: +390226436186
E-mail: ferrari.giulio@hsr.it

Locais de estudo

Itália
- - Milan, Itália, 20132
    - IRCCS San Raffaele Scientific Institute
    - Contato:
      
      Giulio Ferrari, MD, PhD, Professor
      
      Número de telefone: +390226436186
      
      E-mail: ferrari.giulio@hsr.it

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Filho
Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

Inclusion Criteria:

The participant is willing and able to provide written informed consent for study participation (prospective cohort).
Adult participants aged ≥18 years at the time of inclusion.
Clinically confirmed diagnosis of OSD, including but not limited to inflammatory keratopathies, neurotrophic keratopathy, exposure keratopathy, limbal stem cell deficiency, post-surgical or post-traumatic corneal alterations.
Measurable BSCVA obtained through standardized manifest refraction and ETDRS chart testing at baseline.
Available dataset for the diagnostic tests required by the study (e.g., corneal topography, pachymetry, confocal microscopy, corneal sensitivity testing, slit-lamp imaging, tear cytokine analysis, impression cytology).
Willingness and ability to attend follow-up visits and complete all study-related procedures according to the study schedule.

Exclusion Criteria:

Change of retinal, optic nerve, or macular pathology that may affect best spectacle-corrected visual acuity independently of the cornea or ocular surface (e.g., age-related macular degeneration, diabetic macular edema, optic neuropathy) in the period of study
History of intraocular or corneal surgery within 3 months prior to baseline evaluation.
Active intraocular inflammation, glaucoma with uncontrolled intraocular pressure, or corneal conditions not compatible with accurate imaging or measurement (e.g., severe scarring, leukoma).
Uncontrolled systemic diseases that may impair vision or corneal health (e.g., advanced diabetes, autoimmune disease in active phase).
Inability or unwillingness to attend follow-up visits or complete study assessments.
Pregnant or breastfeeding women will not be enrolled, as hormonal fluctuations can alter tear film and ocular surface physiology

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Best spectacle-corrected visual acuity (BSCVA) measured in logMAR Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Maximum keratometry (K max) measured by corneal tomography Prazo: Baseline, 6, and 12 months	Maximum keratometry will be measured by corneal tomography. Unit of Measure is Diopters (D). Higher values indicate greater corneal steepening.	Baseline, 6, and 12 months
Central corneal thickness (CCT) measured by corneal tomography Prazo: Baseline, 6, and 12 months	Central corneal thickness will be measured by corneal tomography. Unit of Measure is micrometers (µm). Lower values indicate greater corneal thinning.	Baseline, 6, and 12 months
Corneal nerve density measured by in vivo confocal microscopy Prazo: Baseline, 6, and 12 months	Corneal nerve density will be measured using in vivo confocal microscopy. Unit of Measure is fibers/mm². Higher values indicate greater corneal nerve density.	Baseline, 6, and 12 months
Corneal sensitivity measured by Cochet-Bonnet esthesiometer Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months
Tear fluid interleukin-1 beta (IL-1β) concentration Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months
Tear fluid interleukin-6 (IL-6) concentration Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months
Tear fluid tumor necrosis factor-alpha (TNF-α) concentration Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months
Tear fluid matrix metalloproteinase-9 (MMP-9) concentration Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months
Inflammatory cell count measured by impression cytology Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months
Intraocular pressure (IOP) measured by Goldmann applanation tonometry Prazo: Baseline, 6, and 12 months	Intraocular pressure will be measured using Goldmann applanation tonometry. Unit of Measure in mmHg. Higher values indicate higher intraocular pressure.	Baseline, 6, and 12 months
Ocular Surface Disease Index (OSDI) score Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months
Ocular Pain Assessment Survey (OPAS) quality-of-life interference score Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months
Visual Analog Scale (VAS) pain score Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months
National Eye Institute Visual Function Questionnaire-25 (VFQ-25) composite score Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months
Standard Patient Evaluation of Eye Dryness (SPEED) score Prazo: Baseline, 6, and 12 months	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.	Baseline, 6, and 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

IRCCS San Raffaele

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2029

Conclusão do estudo (Estimado)

1 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

23 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de julho de 2026

Primeira postagem (Real)

10 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade