Comparison of Treatment With Preservative-free Dexamethasone 0.1% (Monofree Dexamethason) and Diclofenac 0.1% (Dicloabak) Eye Drops Versus Preserved Dexamethasone 0.1% (Maxidex) and Diclofenac 0.1% (Voltaren Ophtha) Eye Drops After Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The superiority of treatment arm without conservative (WC) on treatment arm with conservative (C) on the aqueous flare value in the operated eye, measured with a laser flare meter, at week 4 after cataract surgery.
研究概览
简要总结
To compare treatment with preservative-free dexamethasone 0.1% (Monofree Dexamethason) and diclofenac 0.1% (Dicloabak) eye drops versus preserved dexamethasone 0.1% (Maxidex) and diclofenac 0.1% (Voltaren Ophtha) eye drops after cataract surgery in terms of postoperative inflammation, iatrogenic dry eye disease and cystoid macular edema.
详细描述
Cataract surgery is a standardized procedure yielding excellent visual outcomes in most patients. According to Daien et al., the incidence of cataract surgery in 2012 in France was 11/1000 person-years. Although there are few complications related to the surgery, patients often experience ocular discomfort in the postoperative period.
Postoperative treatment usually includes topical non-steroidal anti-inflammatory drugs and topical steroids for four weeks to control anterior chamber inflammation, to relieve ocular pain after surgery and to reduce the incidence of cystoid macular edema.
Benzalkonium chloride (BAK) is the most common eye drop preservative and is associated with several ocular adverse effects, including dry eye and ocular surface inflammation. Moreover, in two clinical trials comparing the effects of BAK-containing and preservative-free eye drops, anterior chamber inflammation was reported in response to BAK after 1 month of exposure. Finally, besides the fact that intra-ocular inflammation increases the risk of macular edema, there is some evidence in the literature suggesting that BAK may also contribute to the development of macular edema.
Because of these well-established detrimental effects of preservatives, pharmaceutical industry has invested in the development of preservative-free eye drops in the past decade, which has led to preservative-free alternatives for almost all the eye medications.
The aim of this project is to investigate whether omitting preservatives from the postoperative topical treatment after cataract surgery can reduce symptoms and signs of ocular surface disease, intra-ocular inflammation and the incidence of cystoid macular edema.
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
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with age-related cataract
- •Age 60 years or above
排除标准
- •Unwilling to sign informed consent
- •Pseudoexfoliation syndrome
- •Functionally monocular patient
- •Any use of eye drops during at least 3 months before surgery with the exception of artificial tears
- •Pre-existing dry eye disease according to the criteria's of the TFOS DEXS II report
- •Previous ocular surgery, laser treatment or uveitis, with the exception of retinal laser treatment (more than 6 months ago) and iridotomy (more than 6 months ago)
- •Active conjunctivitis
- •Wearing of contact lens
- •Presence of any macular diseases possibly impacting visual acuity
- •Presence of any ocular diseases leading to difficulty to have a correct eye examination
- •Known or suspected allergy to any of the ingredients on the study medications
- •Presence of uncontrolled systemic disease
研究组 & 干预措施
Preservative-free dexamethasone 0.1%/diclofenac 0.1%
One week before surgery, patients will be randomized to either receive the preservative-free dexamethasone 0.1% and diclofenac 0.1% eye drops.
干预措施: Preservative Free drop treatment (Drug)
Preserved dexamethasone 0.1%/diclofenac 0.1%
One week before surgery, patients will be randomized to either receive the preserved dexamethasone 0.1% and diclofenac 0.1% eye drops.
干预措施: Preserved drop treatment (Drug)
结局指标
主要结局
The superiority of treatment arm without conservative (WC) on treatment arm with conservative (C) on the aqueous flare value in the operated eye, measured with a laser flare meter, at week 4 after cataract surgery.
时间窗: 4 weeks
The Laser Flaremeter can measure the protein density in the anterior chamber by counting the photons. Flare Value is expressed in photoncount/ms. 1-9 photoncounts/ms is a normal value. Photoncount/ms from 10-500 is abnormal and indicates an inflamed eye.
次要结局
- Tear-film break up time(4 weeks)
- Tear Osmolarity(4 weeks)
- Conjunctival Hyperemia(4 weeks)
- Corneal Sensitivity(4 weeks)
- Corneal Fluorescein Staining(4 weeks)
- DEQ-5 score(4 weeks)
- Central macular thickness(4 weeks)
- Inflammatory cytokine activities in tears(4 weeks)
- Amount of tears(4 weeks)