Phase I/II Comparative Study of a Single Intraoperative Sub-Tenon's Capsule Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System Versus 1% Prednisolone and 0.3% Ciprofloxacin Eyedrops for Cataract Surgery
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Anterior chamber cell
研究概览
简要总结
The purpose of this study is to compare one intraoperative sub-Tenon's capsule injection of triamcinolone and ciprofloxacin in a biodegradable controlled-release system with conventional prednisolone and ciprofloxacin eye drops to treat ocular inflammation and for infection prophylaxis after cataract surgery.
详细描述
Topical steroids effectively control ocular inflammation, but are associated with the well-recognized problems of patient compliance. Injection of depot corticosteroids into sub-Tenon's capsule is an established method of treating various ocular inflammatory diseases. Its prolonged therapeutic effect has provided the ophthalmologist with an alternative tool for the treatment of different diseases that may be extended to the surgical arena to modulate postoperative inflammation.
The use of topical antibiotic agents poses unique and challenging hurdles for drug delivery, especially because recent reports have suggested that the incidence of endophthalmitis may be increasing. Exploiting the permeability of the sclera, subconjunctival routes may offer a more promising alternative for enhanced drug delivery and tissue targeting compared with topical routes. In theory, the combination of an antibiotic with a steroid in a controlled-release system delivered transscleral could be feasible after cataract surgery to achieve several clinical objectives, i.e., eliminate topical medications, enhance patient compliance, improve drug bioavailability, and protect the patient from infection.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with uncomplicated, senile cataract
- •Best-corrected visual acuity (VA) of 20/100 or better in the fellow eye
排除标准
- •Patients in use of oral or topical anti-inflammatory agents
- •History of steroid-induced ocular hypertension
- •Hypermature cataracts
- •Previous ocular surgery
- •Preexisting uveitis
- •Diabetic retinopathy
- •Corneal disease
结局指标
主要结局
Anterior chamber cell
时间窗: Days 1, 3, 7, 14, and 28 after surgery
Anterior chamber flare
时间窗: Days 1, 3, 7, 14, and 28 after surgery
Intraocular pressure
时间窗: Days 1, 3, 7, 14, and 28 after surgery
Lack of anti-inflammatory response
时间窗: Days 1, 3, 7, 14, and 28 after surgery
Presence of infection
时间窗: Days 1, 3, 7, 14, and 28 after surgery
次要结局
- Conjunctival hyperemia(Days 1, 3, 7, 14, and 28 after surgery)
- Spectacle corrected visual acuity(Day 28 after surgery)
