Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Foreign body sensation
研究概览
简要总结
Primary objective of the study is the assessment of the patients' discomfort and ocular redness following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.
详细描述
Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA) in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group (who will receive Systane Ultra as additional postoperative treatment) and control group (who will receive standard postoperative treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale
排除标准
- •Endothelial cell count less than 1900,
- •IOP-lowering medications,
- •Former incisional surgery,
- •Former diagnosis of corneal disease,
- •Diabetes or autoimmune diseases
- •Former diagnosis of dry eye disease
研究组 & 干预措施
Systane ultra group
Participants in this group were administered systane ultra quid (Alcon, Fort Worth) for two months postoperatively), additionally to tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.
干预措施: Systane Ultra (Drug)
Control group
Participants in this group were administered the standard postoperative medication [tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.]
干预措施: tobradex quid (Standard) (Drug)
结局指标
主要结局
Foreign body sensation
时间窗: 1 month postoperatively
Foreign body sensation will be assessed by a direct 5-scale, Likert type question that will be addressed to the participants at the 30th postoperative day
次要结局
- Corneal Sensitivity(1 month postoperatively)
- Ocular Redness(7 days postoperatively)
研究者
Georgios Labiris
Assistant Professor
Democritus University of Thrace