ISRCTN41154297已完成不适用
Efficacy and Safety Assessment of Azyter® (T1225) in Peri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract Surgery: a pilot phase II randomised controlled trial
aboratoires Thea (France)0 个研究点目标入组 75 人开始时间: 2009年12月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed and dated informed consent
- •2. Male or female aged from 18 to 80 years old
- •3. Uncomplicated cataract
- •4. Scheduled to undergo cataract surgery (phacoemulsification ? foldable intra-ocular lens surgery with injector ? clear corneal incision)
排除标准
- •Patients with the following ophthalmic conditions will be excluded:
- •1. Surgical conditions in the eye to be operated:
- •1.1. Combined surgery.
- •1.2. Other cataract aetiologies than senile or pre-senile cataract.
- •2. Non-surgical conditions in the eye to be operated:
- •2.1. Dacryocystitis and all others pathologies of tears drainage system.
- •2.2. Inflammatory ocular disease (uveitis, herpetic keratitis).
- •2.3. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis).
- •2.4. History of ocular traumatism, infection or inflammation within the last 3 months.
- •3. Ophthalmic condition in the contra lateral eye:
- •3.1. Best corrected visual acuity < 1/10.
- •3.2. Patient already included in the study for phakoexeresis.
- •3.3. History of surgical complication (notably endophthalmitis)
- •4. Ophthalmic condition in either eye:
- •4.1. Presence of glaucoma and/or ocular hypertension history.
- •4.2. Presence of any other ocular pathology such as dry-eye syndrome, allergy in either eye likely to require a topical treatment from Day-15 to Day 5 conjunctival sampling.
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