Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Aurolab
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Suture characteristics
研究概览
简要总结
To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures
详细描述
The sutures are classified into non-absorbable and absorbable sutures. Violet braided polyglycolic acid suture is the synthetic absorbable suture used in wound closure in ophthalmology, cardiology, neurology and plastic & reconstructive surgeries. In ophthalmology, PGA sutures are used in Trabeculectomy (Glaucoma), Orbit and Oculoplasty, Lid and Socket Reconstruction, Squint, ptosis and retinal detachment surgeries.
Glaucoma patients who met the inclusion criteria were recruited for this study. Uniform surgery and suturing technique was performed in all patients (Trabeculectomy with IOL implantation). Surgeon assessed suture characteristics during surgery and wound integrity at the end of surgery.
Patients were followed up during 1 day, 1 month and 3 months post operatively. Visual acuity, Intraocular Pressure (IOP), suture characteristics, wound integrity, inflammation and conjunctival status were examined during each follow up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing Trabeculectomy with IOL implantation
- •Current residence within 60 kms of madurai
排除标准
- •Life threatening illness
- •Immunosuppressive disorders
- •Chronic infection
结局指标
主要结局
Suture characteristics
时间窗: 1 month, 3 months
次要结局
- Conjunctival status(1 month, 3 months)
- Bleb characteristics(1 month, 3 months)