Assessment of the Eye Surface and Subjective Symptoms After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Best corrected visual acuity result
研究概览
简要总结
The goal of this interventional, real world data study is to evaluate the impact of preservatives on the post-cataract ocular surface.
The main question is to learn about an effect of preservatives on the eye surface. The study aims to answer some important questions:
- if the usage of preservatives has an impact on the eye surface healing process after cataract surgery
- if patient comfort and quality of life improve more or more rapidly with preservatives-free eye drops.
Participants will be asked to undergo standard procedure of peri-cataract surgery care and in addition to survey about the ocular surface state.
Researchers will compare group that takes preservatives-free dexamethasone 0.1% with standard dexamethasone 0.01% solution to see if post-surgery eye surface healing properties differ from both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •cataract surgery required defined previously by the eye-care specialist
- •good and clear visibility of the anterior chamber in the pre-surgery status (enables investigators to assess the anterior chamber cell intensity)
- •consent to the study protocol
排除标准
- •diagnosed glaucoma
- •diagnosed previous allergy
- •diagnosed diabetic retinopathy or maculopathy
- •previously diagnosed dry eye disease that requires treatment with multiple artificial tears
- •permanent usage of the eye drops other than artificial tears
- •non-compliance to the study protocol
结局指标
主要结局
Best corrected visual acuity result
时间窗: up to 21 days post-surgery
best corrected visual acuity evaluated with standard ETDRS for distant and for near vision
Ocular staining score result
时间窗: up to 21 days post-surgery
standard staining score - a scale used with the fluorescein stain; higher value expres more severe outcome, normal values are around 0-1. Overal information can be found: https://entokey.com/a-simplified-quantitative-method-for-assessing-keratoconjunctivitis-sicca-from-the-sjogrens-syndrome-international-registry/
Ocular Surface Disease Index survey result
时间窗: up to 21 days post-surgery
a standard survey that patient will preform at each visit
次要结局
- Shirmer test 1 measurement(up to 21 days post-surgery)
- Intraocular pressure measurement(up to 21 days post-surgery)
- Anterior chamber cell intensity measurement(up to 21 days post-surgery)
- SICCA scale assessment(up to 21 days post-surgery)
- Fluorescein Break-up Time assessment(up to 21 days post-surgery)