Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface Diseases (OSD)
10 de julio de 2026 actualizado por: Giulio Ferrari, IRCCS San Raffaele
Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface Diseases: Single Center Retrospective-prospective Clinical Study
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.
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
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 estudio
De observación
Inscripción (Estimado)
1000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Giulio Ferrari, MD, PhD, Professor
- Número de teléfono: +390226436186
- Correo electrónico: ferrari.giulio@hsr.it
Ubicaciones de estudio
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Milan, Italia, 20132
- IRCCS San Raffaele Scientific Institute
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Contacto:
- Giulio Ferrari, MD, PhD, Professor
- Número de teléfono: +390226436186
- Correo electrónico: ferrari.giulio@hsr.it
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Best spectacle-corrected visual acuity (BSCVA) measured in logMAR
Periodo de tiempo: Baseline, 6, and 12 months
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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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum keratometry (K max) measured by corneal tomography
Periodo de tiempo: 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.
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Baseline, 6, and 12 months
|
|
Central corneal thickness (CCT) measured by corneal tomography
Periodo de tiempo: 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
Periodo de tiempo: Baseline, 6, and 12 months
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Corneal nerve density will be measured using in vivo confocal microscopy.
Unit of Measure is fibers/mm².
Higher values indicate greater corneal nerve density.
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Baseline, 6, and 12 months
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Corneal sensitivity measured by Cochet-Bonnet esthesiometer
Periodo de tiempo: Baseline, 6, and 12 months
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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
|
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Tear fluid interleukin-1 beta (IL-1β) concentration
Periodo de tiempo: 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
|
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Tear fluid interleukin-6 (IL-6) concentration
Periodo de tiempo: Baseline, 6, and 12 months
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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
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Tear fluid tumor necrosis factor-alpha (TNF-α) concentration
Periodo de tiempo: Baseline, 6, and 12 months
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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
Periodo de tiempo: 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
Periodo de tiempo: Baseline, 6, and 12 months
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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.
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Baseline, 6, and 12 months
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Intraocular pressure (IOP) measured by Goldmann applanation tonometry
Periodo de tiempo: Baseline, 6, and 12 months
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Intraocular pressure will be measured using Goldmann applanation tonometry.
Unit of Measure in mmHg.
Higher values indicate higher intraocular pressure.
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Baseline, 6, and 12 months
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Ocular Surface Disease Index (OSDI) score
Periodo de tiempo: Baseline, 6, and 12 months
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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.
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Baseline, 6, and 12 months
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Ocular Pain Assessment Survey (OPAS) quality-of-life interference score
Periodo de tiempo: Baseline, 6, and 12 months
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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.
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Baseline, 6, and 12 months
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Visual Analog Scale (VAS) pain score
Periodo de tiempo: Baseline, 6, and 12 months
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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.
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Baseline, 6, and 12 months
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National Eye Institute Visual Function Questionnaire-25 (VFQ-25) composite score
Periodo de tiempo: Baseline, 6, and 12 months
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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.
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Baseline, 6, and 12 months
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Standard Patient Evaluation of Eye Dryness (SPEED) score
Periodo de tiempo: Baseline, 6, and 12 months
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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.
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Baseline, 6, and 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2029
Finalización del estudio (Estimado)
1 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
23 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de julio de 2026
Publicado por primera vez (Actual)
10 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OSD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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