Rebamipide Versus Diquafosol-Cyclosporine for Perioperative Dry Eye Disease in Cataract Surgery: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in Tear Film Breakup Time (TBUT)
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of 2% rebamipide monotherapy versus a combination therapy of 3% diquafosol and 0.05% cyclosporine for the management of dry eye disease in patients undergoing cataract surgery. It will also evaluate the safety and ocular surface stability effects of these treatments during the perioperative period.
The main questions it aims to answer are:
Does rebamipide monotherapy maintain tear film breakup time (TBUT) and prevent corneal damage as effectively as the combination therapy after surgery? How do patient symptoms (OSDI scores) and inflammation markers (MMP-9) change with each treatment?
Researchers will compare the rebamipide group to the diquafosol-cyclosporine combination group to evaluate their effects on perioperative dry eye management.
Participants will:
Use the assigned study eye drops starting 1 month before their cataract surgery and continuing for 3 months after surgery.
Visit the clinic for eye examinations at baseline, the day of surgery, and at 1 week, 1 month, and 3 months postoperatively.
Undergo tests including tear film breakup time measurement, corneal staining, Schirmer's test, and tear MMP-9 level assessments.
详细描述
Dry eye disease (DED) is common in patients undergoing cataract surgery and may worsen during the perioperative period, leading to ocular discomfort and delayed visual recovery. Pharmacologic treatments targeting tear film instability and ocular surface inflammation are therefore important in perioperative management.
This prospective, randomized, parallel-group clinical trial compared two perioperative treatment strategies for DED in patients scheduled for cataract surgery. Eligible participants with pre-existing dry eye disease were randomized in a 1:1 ratio to receive either topical rebamipide 2% monotherapy or combination therapy with topical diquafosol 3% and cyclosporine 0.05%. Study medications were initiated 1 month prior to surgery and continued for 3 months postoperatively.
The primary outcome measure was the change in tear film breakup time (TBUT) during the early postoperative period. Secondary outcome measures included changes in corneal staining graded by the Oxford scale, patient-reported symptoms assessed by the Ocular Surface Disease Index (OSDI), tear secretion measured by Schirmer's test, and ocular surface inflammation evaluated using a tear matrix metalloproteinase-9 (MMP-9) point-of-care immunoassay.
Clinical assessments were performed at baseline, on the day of surgery, and at postoperative week 1, month 1, and month 3. Safety was evaluated by monitoring intraoperative and postoperative adverse events throughout the study period.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults scheduled for cataract surgery
- •Presence of dry eye disease, defined as an Ocular Surface Disease Index (OSDI) score ≥12 and at least one of the following:
- •Tear film breakup time (TBUT) ≤7 seconds
- •Oxford corneal staining grade ≥1
- •Schirmer's test value ≤10 mm/5 min
- •Ability and willingness to comply with the study protocol and follow-up schedule
- •Provision of written informed consent
排除标准
- •Presence of ocular surface or ocular conditions that could affect dry eye status (e.g., active keratitis or ocular infection)
- •Use of topical intraocular pressure-lowering medications
- •History of ocular surgery other than cataract surgery in the study eye
- •Any systemic or ocular condition judged by the investigator to interfere with study participation or outcome assessment
研究组 & 干预措施
Group R
Participants receive topical rebamipide 2% ophthalmic solution four times daily, initiated 1 month before cataract surgery and continued for 3 months postoperatively.
干预措施: Rebamipide 2% ophthalmic solution (Drug)
Group DC
Participants receive topical diquafosol 3% ophthalmic solution four times daily in combination with cyclosporine 0.05% ophthalmic solution twice daily, initiated 1 month before cataract surgery and continued for 3 months postoperatively.
干预措施: Diquafosol 3% ophthalmic solution (Drug)
Group DC
Participants receive topical diquafosol 3% ophthalmic solution four times daily in combination with cyclosporine 0.05% ophthalmic solution twice daily, initiated 1 month before cataract surgery and continued for 3 months postoperatively.
干预措施: Cyclosporine 0.05% ophthalmic solution (Drug)
结局指标
主要结局
Change in Tear Film Breakup Time (TBUT)
时间窗: From baseline to postoperative week 1
Change in tear film breakup time (TBUT) from baseline and during the early postoperative period following cataract surgery, comparing rebamipide monotherapy with diquafosol-cyclosporine combination therapy.
次要结局
- Change in Ocular Surface Disease Index (OSDI) Score(From baseline to 1 and 3 months postoperatively)
- Change in Corneal Staining Grade (Oxford Scale)(From baseline to postoperative week 1, and to 1 and 3 months postoperatively)
- Change in Schirmer's Test Value(From baseline to 1 and 3 months postoperatively)
- Change in Tear Matrix Metalloproteinase-9 (MMP-9) Level(From baseline to 1 and 3 months postoperatively)
研究者
Dong Hui Lim
Associate Professor
Samsung Medical Center