跳至主要内容
临床试验/NCT06262737
NCT06262737招募中不适用

Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
OSDI

研究概览

简要总结

The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF.

详细描述

The recrutement of the patient is done during the inclusion of the patient by the nurses of the ophtalmological service of clermont-ferrand and confirm by an ophtalmologist of the service.

A mesure of the OSDI is done before the injection, then at 1 day, on week by a phone call. Each of this mesures are done for the 2 other injections.

Before each of this injection, a clinical mesure is done by a lacrydiag: the atrophy of the meibomian glands, the non-invasive break-up time, interferometry, the heigh of the tear meniscum.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with exsudative age-related macular degeneration, diabetic macular edema or retinal vein occlusion
  • Patient with 3 ocular intravitreal injections of anti-VEGF in one eye

排除标准

  • pregnant or breastfeeding woman
  • intravitreal injection before the study
  • intravitreal injection in both eyes
  • allergy of betadine
  • guardianship patient

结局指标

主要结局

OSDI

时间窗: before the injection and at 1 day

Ocular Surface Disease Index: 12 questions treating of either the sensation, the visual impact and the environemental impact of the dry eye disease

次要结局

  • HM(before each injection)
  • AM(before each injection)
  • NIBUT 2(before each injection)
  • OSDI(before the injection and at 1 week)
  • NIBUT 1(before each injection)
  • Interferometry(before each injection)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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