Evaluation de la gêne Oculaire après Injections intravitréennes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients
研究概览
简要总结
In this study, ocular discomfort following intravitreal injection in naïve patients will be studied, as well as the efficacy of wetting agent (Optive eyewash) to prevent ocular discomfort.
详细描述
In naive patients, the two first intravitreal injections will be studied. Within the first injection, no wetting agent will be delivered. Within 72hours after this first intravitreal injections, patients will be contacted by phone by a nurse to complete questionnaires on quality of life and on ocular pain and eye discomfort.
After the second injection, a treatment with wetting agent will be prescribed. With 72hours after the second injection, quality of life, ocular discomfort as well as acceptability and tolerance of the eye drops will also be assessed by a phone questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years old
- •Patient with social healthcare
- •Patient understanding French language
- •Patient requiring anti-VEGF treatment by intravitreal injection
排除标准
- •Patient treated by Ozurdex® before
- •Patient with known and treated ocular dryness
- •Non naive patient for intravitreal injection
- •Hypersensitivity to Carmellose
- •Patient who received wetting agent within the 3 last months
- •History of povidone-iodine allergy
- •Pregnant or breastfeeding mother
研究组 & 干预措施
Optive after the second anti-VEGF injection
Naive patients requiring intravitreal injection. Patients will be enrolled in this study within the 2 first intravitreal injections to assess quality of life and ocular discomfort without wetting agent (ie after the first injection) and with wetting agent (ie after the second injection)
干预措施: Optive (Drug)
结局指标
主要结局
Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients
时间窗: within the 72h after the first and the second intravitreal injections
次要结局
未报告次要终点
研究者
Oudy SEMOUN
Doctor in ophtalmology
Centre Hospitalier Intercommunal Creteil