신경영양성 각막병증, 각막 질환, 윤부 줄기 세포 결핍증(LSCD), 각막 염증, 각막 이상, Exposure Keratopathy에 대한 임상 시험 - 임상 시험 레지스트리

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

1000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Giulio Ferrari, MD, PhD, Professor
전화번호: +390226436186
이메일: ferrari.giulio@hsr.it

연구 장소

이탈리아
- - Milan, 이탈리아, 20132
    - IRCCS San Raffaele Scientific Institute
    - 연락하다:
      
      Giulio Ferrari, MD, PhD, Professor
      
      전화번호: +390226436186
      
      이메일: ferrari.giulio@hsr.it

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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어린이
성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

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주요 결과 측정

결과 측정	측정값 설명	기간
Best spectacle-corrected visual acuity (BSCVA) measured in logMAR 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Maximum keratometry (K max) measured by corneal tomography 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

IRCCS San Raffaele

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

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