Comparative Study of the Efficacy and Safety of Ologen Collagen Implant Versus Cohesive Viscoelastic in Trabeculectomy Performed for Steroid Induced Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of this prospective randomized study is to assess and compare the clinical efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled steroid induced glaucoma.
详细描述
Steroid induced glaucoma is a well known and widely described disastrous clinical condition. However the subject of selection of most effective and safe treatment modality is still being discussed.
Sihota R et al reported that 26.5% cases required surgical treatment to control IOP. Unfortunately survival rate of successful blebs in 10 years after trabeculectomy varies from 40% to 60%. Anti-fibrotic agent MMC as adjunct to filtration surgery was used to prevent postoperative scarring that could compromise surgical success of trabeculectomy. Additional use of MMC in trabeculectomy leads to low final IOP but could be associated with such complications as cataract formation, intraocular toxicity, avascular filtering blebs, wound leakage, subsequent blebitis and endophthalmitis. Tissue-engineered biodegradable and biocompatible implant Ologen® Collagen Matrix may be used as an alternative to MMC. Ologen® is CE Mark and FDA approved artificial porcine extracellular matrix for modulating wound healing. Ologen® has been tested in animal models and has triple action:
- prevent the collapse of the subconjunctival space;
- guides the fibroblast to grow through the matrix pores thus preventing scar formation;
- may act as an aqueous reservoir (avoids post-op hyperfiltration and shallow anterior chamber).
The filtering blebs scoring was performed by using Moorfields Bleb Grading System and Visante anterior segment optical coherence tomography.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 16 years (inclusive)
- •Patients with medically uncontrolled steroid induced glaucoma
排除标准
- •Primary open angle glaucoma, angle-closure glaucoma, post-traumatic, uveitic, neovascular, or dysgenetic glaucoma
- •Known allergic reaction to porcine collagen
- •Preliminary conjunctival damage (trauma, vitreo-retinal surgery, previous glaucoma or strabismus surgery, etc)
研究组 & 干预措施
Implantation of Ologen in trabeculectomy
Ologen Collagen Matrix is implanted in primary limbal-based trabeculectomy. It should be placed on the top of the loosely-sutured scleral flap before suturing of the conjunctiva thus preventing the collapse of the subconjunctival space.
干预措施: Ologen Collagen Matrix (Device)
Provisc in trabeculectomy
Provisc is used in primary limbal-based trabeculectomy. At the end of the surgery cohesive viscoelastic (Provisc) is injected under the scleral flap to prevent early hypotony.
干预措施: Provisc (Drug)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: 2 years
The absolute success was defined as an IOP less than 21 mmHg with no glaucoma medications. Follow-up visits were and will arranged at 1 and 2 first weeks, then every month during first 6 months, then every 3 months during 2.5 years after surgery.
次要结局
- Postoperative complications(2 years)
- Corrected distance visual acuity (CDVA)(2 years)
- Appearance of the filtering bleb (FB)(2 years)