Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface Diseases

Starting soon

Conditions studied: Neurotrophic Keratopathy, Exposure Keratopathy, Limbal Stem Cell Deficiency (LSCD), Cornea Abnormality, Cornea Disease, Cornea Inflamed

In brief

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.

Key facts

Study ID

NCT07694817

Run by

IRCCS San Raffaele

People needed

1000

Starts

2026-07-01

Expected to finish

2029-12-01

Last updated by the study team

2026-07-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• IRCCS San Raffaele Scientific Institute — Milan, Italy

Full record on ClinicalTrials.gov

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