About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
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
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Best spectacle-corrected visual acuity (BSCVA) measured in logMAR
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.
Secondary outcomes
Maximum keratometry (K max) measured by corneal tomography
Maximum keratometry will be measured by corneal tomography. Unit of Measure is Diopters (D). Higher values indicate greater corneal steepening.
Central corneal thickness (CCT) measured by corneal tomography
Central corneal thickness will be measured by corneal tomography. Unit of Measure is micrometers (µm). Lower values indicate greater corneal thinning.
Corneal nerve density measured by in vivo confocal microscopy
Corneal nerve density will be measured using in vivo confocal microscopy. Unit of Measure is fibers/mm². Higher values indicate greater corneal nerve density.
Corneal sensitivity measured by Cochet-Bonnet esthesiometer
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.
Sponsors and contacts
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