Investigation of the Efficacy and Safety of Preoperative Intraocular Pressure (IOP) Reduction With Preservative-free COSOPT-S® (Dorzolamide/Timolol, MSD) Eye Drops Versus Oral Acetazolamide and Dexamethasone Eye Drops
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP
研究概览
简要总结
The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs, controlling IOP with oral acetazolamide, and treating the eye with local steroids.
Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP preoperatively with the aim of avoiding postoperative excessive scarring and the known adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term outcomes.
This study will investigate comparability (non-inferiority) of medical benefits of two different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing COSOPT-S® bid to oral acetazolamide plus dexamethasone.
详细描述
The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs, controlling IOP with oral acetazolamide, and treating the eye with local steroids.
Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP preoperatively with the aim of avoiding postoperative excessive scarring and the known adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term outcomes.
This study will investigate comparability (non-inferiority) of medical benefits of two different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing COSOPT-S® bid to oral acetazolamide plus dexamethasone.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 years or older
- •Caucasian
- •A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
- •Planned trabeculectomy
- •Previous treatment with antiglaucoma agents containing preservatives for at least one month
- •Best corrected visual acuity of 20/800 or better in the study eye
排除标准
- •Secondary glaucoma except pseudoexfoliation glaucoma and pigmentary glaucoma
- •Current ocular infection, i.e. conjunctivitis or keratitis
- •Any abnormality preventing reliable applanation tonometry
- •Intraocular surgery or laser treatment within the past three months
- •History of surgery involving the conjunctiva
- •History of cataract surgery with sclerocorneal approach
- •Subject is allergic to sulfonamides
- •Reactive airway disease, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
- •Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
- •Severe renal dysfunction (CrCl < 30 ml/min) or hyperchloraemic acidosis
- •Depressed blood levels of sodium and / or potassium
- •Marked kidney and liver disease or dysfunction, gout, suprarenal gland failure, hypercalciuria or nephrocalcinosis
- •History of hypersensitivity to the investigational medicinal products or to any drug
研究组 & 干预措施
Diamox/DexaEDO
Patients receive Diamox (oral acetazolamide) starting 28 days Prior to trabeculectomy. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Patient will undergo trabeculectomy.
干预措施: Trabeculectomy with preoperative Diamox/DexaEDO treatment (Drug)
Cosopt S
Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.
干预措施: Trabeculectomy with preoperative Cosopt S treatment (Drug)
结局指标
主要结局
Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP
时间窗: 12 weeks
Change in IOP (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP at one day prior surgery
次要结局
- Number of Needling(12 weeks)
- Number of Necessary 5-Fluorouracil (5FU) Injections(12 weeks)
- Ocular Hypotension Rate(24 weeks)
- Change in IOP Between Visit 1 and 2(28 days)
- Filtration Bleb Classification(24 weeks)
- Change in Quality of Life(12 weeks)
- Change in Conjunctival Redness(24 weeks)
- Number of Suture Lyses(week 12)
研究者
Katrin Lorenz
MD
Johannes Gutenberg University Mainz