Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface Diseases: Single Center Retrospective-prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Best spectacle-corrected visual acuity (BSCVA) measured in logMAR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Best spectacle-corrected visual acuity (BSCVA) measured in logMAR
时间窗: 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.
次要结局
- Maximum keratometry (K max) measured by corneal tomography(Baseline, 6, and 12 months)
- Central corneal thickness (CCT) measured by corneal tomography(Baseline, 6, and 12 months)
- Corneal nerve density measured by in vivo confocal microscopy(Baseline, 6, and 12 months)
- Corneal sensitivity measured by Cochet-Bonnet esthesiometer(Baseline, 6, and 12 months)
- Tear fluid interleukin-1 beta (IL-1β) concentration(Baseline, 6, and 12 months)
- Tear fluid interleukin-6 (IL-6) concentration(Baseline, 6, and 12 months)
- Tear fluid tumor necrosis factor-alpha (TNF-α) concentration(Baseline, 6, and 12 months)
- Tear fluid matrix metalloproteinase-9 (MMP-9) concentration(Baseline, 6, and 12 months)
- Inflammatory cell count measured by impression cytology(Baseline, 6, and 12 months)
- Intraocular pressure (IOP) measured by Goldmann applanation tonometry(Baseline, 6, and 12 months)
- Ocular Surface Disease Index (OSDI) score(Baseline, 6, and 12 months)
- Ocular Pain Assessment Survey (OPAS) quality-of-life interference score(Baseline, 6, and 12 months)
- Visual Analog Scale (VAS) pain score(Baseline, 6, and 12 months)
- National Eye Institute Visual Function Questionnaire-25 (VFQ-25) composite score(Baseline, 6, and 12 months)
- Standard Patient Evaluation of Eye Dryness (SPEED) score(Baseline, 6, and 12 months)
研究者
Giulio Ferrari
Professor
IRCCS San Raffaele