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

2026年7月10日 更新者：Giulio Ferrari、IRCCS San Raffaele

Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface Diseases: Single Center Retrospective-prospective Clinical Study

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.

研究概览

地位

尚未招聘

条件

详细说明

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.

Overall study duration: Approximately 60 months. Retrospective phase: a cohort of 1,500 patients will be selected among those patients who have been visited at the Cornea Clinic of the OSR in the last 20 years (starting from 01 Jan 2005 to 31 dec 2025) and who have a follow up of at least 12 months. Prospective phase: the investigators will enroll a cohort of 1,000 patients who will be rectruited among those visited at the Cornea Clinic of the OSR and who will be followed up for minimum 12 months. Recruitment will be ongoing for 48 months and the last patient will exit the study by month 60.

Individual patient duration: up to 12 months (baseline, 6-, and 12- month visits).

Interim analyses are planned at multiple time points throughout the study, contingent on data availability and sample size progression. The precise timing of these analyses will be determined based on the pace of data collection and event occurrence, rather than fixed calendar dates.

All data will be collected using standardized, validated diagnostic methods:

  • Corneal topography (maximum keratometry, Kmax) and pachymetry
  • In vivo confocal microscopy (corneal nerve density and cellular morphology)
  • Slit-lamp photography (conjunctival hyperemia and corneal opacity grading)
  • Cochet-Bonnet esthesiometer (corneal sensitivity)
  • Goldmann applanation tonometry (intraocular pressure)
  • Tear cytokine quantification (including IL-1β, IL-6, TNF-α, MMP-9, multiplex immunoassay)
  • Impression cytology (inflammatory cell counts)
  • Ocular pain/quality of life questionnaire scores (OSDI, OPAS, VAS, VFQ25, SPEED)

Retrospective data will be extracted from electronic medical records, while prospective data will be entered into a dedicated electronic case report form (eCRF) using harmonized acquisition protocols.

研究类型

观察性的

注册 (估计的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Giulio Ferrari, MD, PhD, Professor
  • 电话号码：+390226436186
  • 邮箱：ferrari.giulio@hsr.it

学习地点

  • 意大利
      • Milan、意大利、20132
        • IRCCS San Raffaele Scientific Institute
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Best spectacle-corrected visual acuity (BSCVA) measured in logMAR
大体时间：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.
Baseline, 6, and 12 months

次要结果测量

结果测量
措施说明
大体时间
Maximum keratometry (K max) measured by corneal tomography
大体时间：Baseline, 6, and 12 months
Maximum keratometry will be measured by corneal tomography. Unit of Measure is Diopters (D). Higher values indicate greater corneal steepening.
Baseline, 6, and 12 months
Central corneal thickness (CCT) measured by corneal tomography
大体时间：Baseline, 6, and 12 months
Central corneal thickness will be measured by corneal tomography. Unit of Measure is micrometers (µm). Lower values indicate greater corneal thinning.
Baseline, 6, and 12 months
Corneal nerve density measured by in vivo confocal microscopy
大体时间：Baseline, 6, and 12 months
Corneal nerve density will be measured using in vivo confocal microscopy. Unit of Measure is fibers/mm². Higher values indicate greater corneal nerve density.
Baseline, 6, and 12 months
Corneal sensitivity measured by Cochet-Bonnet esthesiometer
大体时间：Baseline, 6, and 12 months
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.
Baseline, 6, and 12 months
Tear fluid interleukin-1 beta (IL-1β) concentration
大体时间：Baseline, 6, and 12 months
Interleukin-1 beta concentration will be measured in tear fluid samples by tear film analysis. Unit of Measure is pg/mL. Higher values indicate greater inflammatory activity.
Baseline, 6, and 12 months
Tear fluid interleukin-6 (IL-6) concentration
大体时间：Baseline, 6, and 12 months
Interleukin-6 concentration will be measured in tear fluid samples by tear film analysis. Unit of Measure is pg/mL. Higher values indicate greater inflammatory activity.
Baseline, 6, and 12 months
Tear fluid tumor necrosis factor-alpha (TNF-α) concentration
大体时间：Baseline, 6, and 12 months
Tumor necrosis factor-alpha concentration will be measured in tear fluid samples by tear film analysis. Unit of Measure is pg/mL. Higher values indicate greater inflammatory activity.
Baseline, 6, and 12 months
Tear fluid matrix metalloproteinase-9 (MMP-9) concentration
大体时间：Baseline, 6, and 12 months
Matrix metalloproteinase-9 concentration will be measured in tear fluid samples by tear film analysis. Unit of Measure is ng/mL. Higher values indicate greater inflammatory activity.
Baseline, 6, and 12 months
Inflammatory cell count measured by impression cytology
大体时间：Baseline, 6, and 12 months
Inflammatory cell count will be measured using impression cytology of the ocular surface. Unit of Measure is cells/mm². Higher values indicate greater ocular surface inflammation.
Baseline, 6, and 12 months
Intraocular pressure (IOP) measured by Goldmann applanation tonometry
大体时间：Baseline, 6, and 12 months
Intraocular pressure will be measured using Goldmann applanation tonometry. Unit of Measure in mmHg. Higher values indicate higher intraocular pressure.
Baseline, 6, and 12 months
Ocular Surface Disease Index (OSDI) score
大体时间：Baseline, 6, and 12 months
Ocular surface symptoms and vision-related function will be assessed using the Ocular Surface Disease Index questionnaire. The total score ranges from 0 to 100, with higher scores indicating more severe ocular surface disease symptoms.
Baseline, 6, and 12 months
Ocular Pain Assessment Survey (OPAS) quality-of-life interference score
大体时间：Baseline, 6, and 12 months
Pain-related interference with quality of life will be assessed using the Ocular Pain Assessment Survey quality-of-life interference score. The score ranges from 0 to 10, where 0 indicates no interference with quality of life and 10 indicates maximum interference with quality of life. Higher scores indicate worse pain-related quality-of-life impairment.
Baseline, 6, and 12 months
Visual Analog Scale (VAS) pain score
大体时间：Baseline, 6, and 12 months
Ocular pain will be assessed using a Visual Analog Scale. The score ranges from 0 to 10, where 0 indicates no ocular pain and 10 indicates the worst imaginable ocular pain. Higher scores indicate worse ocular pain.
Baseline, 6, and 12 months
National Eye Institute Visual Function Questionnaire-25 (VFQ-25) composite score
大体时间：Baseline, 6, and 12 months
Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25. The composite score ranges from 0 to 100, where 0 indicates the worst possible vision-related quality of life and 100 indicates the best possible vision-related quality of life. Higher scores indicate better vision-related quality of life.
Baseline, 6, and 12 months
Standard Patient Evaluation of Eye Dryness (SPEED) score
大体时间：Baseline, 6, and 12 months
Dry eye symptoms will be assessed using the Standard Patient Evaluation of Eye Dryness questionnaire. The total score ranges from 0 to 28, where 0 indicates no dry eye symptoms and 28 indicates the most severe dry eye symptoms. Higher scores indicate worse dry eye symptoms.
Baseline, 6, and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

IRCCS San Raffaele

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2026年6月23日

首先提交符合 QC 标准的

2026年7月4日

首次发布 (实际的)

2026年7月10日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月10日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • OSD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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