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临床试验/NCT00431028
NCT00431028终止1 期

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

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2005年9月1日最近更新:
适应症

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

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)

研究者

发起方
Federal University of São Paulo
申办方类型
Other

研究点 (2)

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