Patient Satisfaction,Dry Symptoms in Patients Cataract Surgery in NHS Patients Treated With Prophylactic Preservative-free Lubricant Eye Drops (AEONTM Repair, and AEONTM Protect Plus): A Randomized, Prospective, Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- CATPROM 5 patient satisfaction score
研究概览
简要总结
Patient satisfaction and dry symptoms in patients undergoing routine uncomplicated cataract surgery in NHS patients treated with prophylactic phosphate-free, preservative-free lubricant eye drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and0.15% Sodium Hyalu-ronate with vitamins A and E, AEONTM Repair): A randomized, prospective, controlled study.
详细描述
The aim of this study is to investigate the routine use of such lubricating drops in a randomized, prospective methodology in patients undergoing uncomplicated cataract surgery in the NHS setting. As these drops are provided with the intraocular lens, if found to be of benefit in reducing dry eye problems such a study might provide evidence for the universal implementa-tion of post-operative ocular lubricant drops
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilateral or unilateral cataracts requiring surgical intervention
- •Age over 18 years
- •Able to understand informed consent and the objectives of the trial
- •Not pregnant, not breast feeding
- •No previous eye surgery
排除标准
- •age-related macula degeneration
- •previous retinal vascular disorders
- •previous retinal detachment or tear
- •any neuro-ophthalmological condition
- •any inherited retinal disorder or pathology
- •previous strabismus surgery or record of amblyopia
- •previous TIA, CVA or other vaso-occlusive disease
- •already enrolled in another study
- •already on prescribed lubricating drops
研究组 & 干预措施
Standard Treatment plus lubricating drops
Lubricant eye-drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vita-mins A and E (AEONTM Repair) for 6 weeks post-Cataract surgery, in addition to the standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks
干预措施: AEONTM Repair and AEONTM Protect Plus lubricating eye drops (Drug)
结局指标
主要结局
CATPROM 5 patient satisfaction score
时间窗: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Quality of life patient satisfaction questionnaire
EQ5D3L patient satisfaction score
时间窗: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Quality of life patient satisfaction questionnaire
Dry Eye Symptoms
时间窗: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Patient questionnaire SPEED II score (Maximum 28, Minimum 0)
次要结局
- Cornea and Conjunctival Staining(2 week follow up and 2 month follow up)
- Corneal Incision site and size(2 week follow up and 2 month follow up)
- Schirmer 1 Test(2 week follow up and 2 month follow up)
- Tear Break up time(2 week follow up and 2 month follow up)
- Inferior tear meniscus(2 week follow up and 2 month follow up)
- Visual Acuity(2 week follow up and 2 month follow up)