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Observational
Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface Diseases
Condition(s) studied
Neurotrophic KeratopathyExposure KeratopathyLimbal Stem Cell Deficiency (LSCD)Cornea AbnormalityCornea DiseaseCornea Inflamed
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Best spectacle-corrected visual acuity (BSCVA) measured in logMAR — 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.
Trial sites (1)
| Facility | City | Region | Status |
| IRCCS San Raffaele Scientific Institute |
Milan |
Italy |
|
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