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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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

1000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Giulio Ferrari, MD, PhD, Professor
  • 電話番号：+390226436186
  • メール：ferrari.giulio@hsr.it

研究場所

  • イタリア
      • Milan、イタリア、20132
        • IRCCS San Raffaele Scientific Institute
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Best spectacle-corrected visual acuity (BSCVA) measured in logMAR
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Maximum keratometry (K max) measured by corneal tomography
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

IRCCS San Raffaele

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2029年12月1日

研究の完了 (推定)

2029年12月1日

試験登録日

最初に提出

2026年6月23日

QC基準を満たした最初の提出物

2026年7月4日

最初の投稿 (実際)

2026年7月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月14日

QC基準を満たした最後の更新が送信されました

2026年7月10日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • OSD

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