Role of Postoperative Lubrication in Preventing Dry Eye After Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of dry eye symptoms defined by OSDI score >= 13 at 3 months visit
研究概览
简要总结
Cataract and dry eye are two conditions occurring frequently in the elderly. Several reports suggested a deterioration of dry eye after cataract surgery, causing a significant impact on patients' postoperative satisfaction as well as quality of life. Recently, a novel index, assessing the risk of developing dry eye after cataract surgery in a non-dry eye population, was published; the so called - Ocular Surface Frailty Index (OSFI). This score utilizes 10 items including clinical ocular findings, medical history as well as environmental factors and grade the respective subject in low-risk- or high-risk group. Using the cutoff of 0.3, the rate of postoperative dry eye was 9,6% in the low-risk group and 50% in the high-risk group (p<0.001).
Systane Hydration MDPF eye drops (Alcon Research, Ltd., Fort, Worth, Texas, USA, a division of Novartis) is an artificial tear substitute based on the dual-polymer formula containing HP-Guar and hyaluronic acid. Previous studies found an increase in tear film stability and reduction of subjective complaints. In an animal model corneas treated with Systane Hydration showed the fastest re-epithelialization compared to other HA products supporting the beneficial role of HA-containing artificial tears in corneal wound healing.
The current study seeks to investigate if intensive lubrication, using Systane Hydration MDPF, in the postoperative phase of cataract surgery can reduce the rate of dry eye in the high-risk group. The findings will have a great impact how to identify these patients, to administer the adequate therapy, which might hinder development of dry eye related to cataract surgery.
The goal of this clinical trial is to learn if Systane Hydration MDPF eye drops (Alcon Research, Ltd., Fort, Worth, Texas, USA, a division of Novartis) works to treat prevent postoperative dry eye in adults undergoing cataract surgery. The main questions it aims to answer are:
- to investigate if intensive lubrication, using Systane Hydration MDPF, in the postoperative phase of cataract surgery can reduce the rate of dry eye in a high-risk group. The findings will have a great impact how to identify these patients, to administer the adequate therapy, which might hinder development of dry eye related to cataract surgery.
Participants will:
Take Systane Hydration MDPF eye drops 4x daily for 3 months additional to or just the standard of care medication (NSAID topical 2x daily for 4 weeks) after surgery Visit the clinic after 7 days, 1 month and 3 months after cataract surgery
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator will be masked to study group allocation
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
- •Age older than 18 years
- •Cataract surgery scheduled in one or both eyes
- •Scheduled for monofocal or monofocal-toric IOL implantation
- •OSDI lower than 14
- •OSFI higher or equal to 0.3 - Group 1 and Group 2
- •OSFI lower than 0.3 - Group 3
排除标准
- •Presence of dry eye symptoms preoperatively
- •Occurrence of complications during surgery
- •Usage of systemic antibiotic therapy
- •Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
- •Ocular surgery within prior 3 months
- •Ocular injury within prior 3 months
- •Ocular herpes of eye or eyelid within prior 3 months
- •Active ocular infection
- •Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
- •Eyelid abnormalities that affect lid function
- •Ocular surface abnormality that may compromise corneal integrity
- •Pregnancy
研究组 & 干预措施
High Risk Standard of Care
OSFI >= 0.3, NSAID 2x daily for 4 weeks
High Risk Treatment Group
OSFI >= 0.3, NSAID 2x daily for 4 weeks, Systane Hydration MDPF 4x daily for 3 months
干预措施: Systane Hydration MDPF eye drops (Device)
Low Risk, Reference Group
OSFI < 0.3, NSAID 2x daily for 4 weeks
结局指标
主要结局
Rate of dry eye symptoms defined by OSDI score >= 13 at 3 months visit
时间窗: 3 months visit
次要结局
未报告次要终点
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Prim. Prof. Dr.
Vienna Institute for Research in Ocular Surgery