Patient Satisfaction and Dry Symptoms in NHS Patients Undergoing Routine Uncomplicated Cataract Surgery Treated With Prophylactic Phosphate-free, Preservative-free Lubricant Eye Drops. A Randomised Controlled Prospective Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Patient Satisfaction (CatPROM 5)
研究概览
简要总结
This is a randomised controlled trial to assess the use of prophylactic lubricant eye-drops for 6 weeks following uncomplicated, routine cataract surgery to improve patient satisfaction and symptoms of dry eye, compared to controls.
详细描述
On entry into the study patients will be randomized to receive either lubricant eye-drops (phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vitamins A and E (AEONTM Repair) to be administered four times a day for 6 weeks following surgery (in addition to the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks) or no additional lubricant drops in addition to the usual medications described above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
研究组 & 干预措施
Experimental Arm
Experimental arm receives lubricant eye-drops (phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vitamins A and E (AEONTM Repair) to be administered four times a day for 6 weeks following cataract surgery (in addition to the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks).
干预措施: AEONTM Repair (Drug)
Experimental Arm
Experimental arm receives lubricant eye-drops (phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vitamins A and E (AEONTM Repair) to be administered four times a day for 6 weeks following cataract surgery (in addition to the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks).
干预措施: Routine post-operative eye drops used. (Other)
Control Arm
The control arm group receive the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks after cataract surgery.
干预措施: Routine post-operative eye drops used. (Other)
结局指标
主要结局
Patient Satisfaction (CatPROM 5)
时间窗: 6 weeks
Validated patient satisfaction questionnaire are used. Specially designed and validated conversion tables are used to convert raw scores from questionnaires to Rasch calibrated measures.
Self-reported Health Outcome
时间窗: 6 weeks
A validated self-reported health questionnaire is used where a descriptive and vertical Visual Analogue Scale (VAS) are used. The descriptive scale assesses 5 domains at three levels of difficulty (no / some / extreme problems). The VAS is used to to record patients' self-reported health on a scale from 0-100 (100/100 being excellent health, 0/100 being very poor health.
Patient Reported Symptoms (Speed II questinnaire)
时间窗: 6 weeks
A validated questionnaire is used with a grading system to grade severity of dry eye . symptoms. Score out of 28. Higher the score, the more significant the dry eye symptoms.
次要结局
- Visual Acuity(6 weeks)
- Tear Break up Time(6 weeks)
- Cornea and Conjunctival Staining Scores(6 weeks)
- Cataract incision site and size(6 weeks)
- Schirmer 1 test(6 weeks)