Comparison of Porcine Submucosal Tissue Patch Graft (KeraSys) Versus Processed Pericardium Patch Graft (Tutoplast) in Glaucoma Drainage Implant Surgery Using a Molteno 3 Shunt
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Kerasys safety
研究概览
简要总结
The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery
详细描述
This study compares patients who will undergo Molteno 3 shunt implant surgery with 1 group receiving KeraSys patch graft and the 2nd group receiving Tutoplast patch graft. The investigators will examine the efficacy and safety of KeraSys in comparison with Tutoplast and monitor the long term effectiveness for preventing tube erosion in Molteno 3 tube shunt surgery for 1 year.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma
排除标准
- •Age ≤ 18 years old.
- •Any type of glaucoma other than those listed in the inclusion criteria.
- •Less than 3 months of other ocular surgery.
- •Active thyroid-related immune orbitopathy, carotid-cavernous fistula, Sturge Weber syndrome, orbital tumors or orbital congestive disease.
- •Patients with connective tissue disorder.
- •Patients with congenital or developmental glaucoma.
- •Patients with severe dry eye syndrome.
- •Patients with any surgical procedure involving revision, removal, or change of the existing glaucoma tube shunt.
- •Patients undergoing any surgical concomitant surgical procedure involving the posterior segment.
- •Patients with active scleritis, history of ocular trauma including chemical burn, chronic ocular inflammatory disease, or ocular surface disease.
- •Patients with any prior history of allergy to the active compound.
- •Pregnancy or breast-feeding.
- •Patients enrolled in other prospective clinical trials.
- •Patients that plan to use contact lens after surgery.
研究组 & 干预措施
KeraSys Tissue Patch Graft
20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft
干预措施: Molteno 3 glaucoma drainage shunt (Procedure)
Tutoplast tissue patch graft
20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft
干预措施: Molteno 3 glaucoma drainage shunt (Procedure)
结局指标
主要结局
Kerasys safety
时间窗: one day, week one, 1 month, 3 month, 6 month, and 1 year
The patch graft will be graded on appearance at each visit by slit lamp for tube erosion and conjunctival retraction.
次要结局
- Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery(1 month, 3 month, 6 month, 1 year)
研究者
Marlene Moster, MD
Marlene Moster, MD Principal Investigator, Wills Eye Institute Glaucoma Department
Wills Eye