Impact of 0.1% Sodium Hyaluronate and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Cataract Extraction Surgery, a Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Surface Discomfort Index
研究概览
简要总结
Primary objective of the study is the assessment of the patients' discomfort 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), the Naval Hospital in Athens, the Papanikolaou General Hospital in Thessaloniki, and Athinaiki General Clinic in Athens 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 fixed combination of tobramycin and dexamethasone (FCTD), (Tobradex, Alcon, Greece) quid for 3 weeks and 0.2 % sodium hyaluronate (Hylogel, Pharmex, Greece) quid for 6 weeks], and control group [who will receive Tobradex quid for 3 weeks and 0.1 % sodium hyaluronate (Hylocomod) quid for 6 weeks].
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
- 50 Years 至 85 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
- •Diagnosis or evidence of dry-eye-disease (DED)
- •IOP-lowering medications
- •Former incisional surgery
- •Former diagnosis of corneal disease
- •Autoimmune diseases
- •Mental diseases
研究组 & 干预措施
Study group
Sodium Hyaluronate 0.1% drops
干预措施: Sodium Hyaluronate 0.2% drops (Drug)
Control group
Sodium Hyaluronate 0.2% drops
干预措施: Sodium Hyaluronate 0.1% drops (Drug)
结局指标
主要结局
Surface Discomfort Index
时间窗: 6 weeks
A subjective parameter that quantifies corneal discomfort
次要结局
- Break up time(6 weeks)
- Central Corneal Sensitivity(6 weeks)
研究者
Georgios Labiris
Associate Professor of Ophthalmology
Democritus University of Thrace