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Starting soon Observational

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

NCT07694817 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-07
Last updated
2026-07-14

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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
IRCCS San Raffaele Scientific Institute Milan Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07694817 on ClinicalTrials.gov ↗ ← All trials in Italy