Modified Trabeculectomy With an Extended Subscleral Tunnel Versus Conventional Trabeculectomy for Management of Primary Open Angle Glaucoma (POAG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change from baseline intraocular pressure at 3 months
研究概览
简要总结
- To evaluate prospectively the surgical outcome in terms of intraocular pressure control, potential advantages, disadvantages, success rate, complications and bleb morphology of this modified trabeculectomy with an extended subscleral tunnel (ESST) in comparison to the conventional subscleral trabeculectomy (SST) in management of uncontrolled primary open angle glaucoma.
- This study will recruit 40 eyes of (40) candidate patients with primary open angle glaucoma (POAG) who are indicated for surgery.
- The candidate patients will be recruited into 2 equal comparative groups. In group (A) 20 eyes (20 patients) who will undergo conventional (SST) with intraoperative mitomycin C (MMC) (0.03%) and group (B); 20 eyes of 20 patients will undergo trabeculectomy with an ESST also with intraoperative adjunctive MMC (0.03%).
详细描述
- Different surgical procedures were developed and the principle behind them was to establish a fistula between the anterior chamber and the subconjunctival space to permit the aqueous humour to exit the eye.
- Subscleral trabeculectomy has remained the most commonly performed glaucoma surgery to which the newer operations are compared.Although this procedure is very effective in reducing intraocular pressure (IOP) immediately, surgical failure has often been observed over time due to fibrosis of the surgical site and resultant non-filtering bleb. -Improvement of the complication profile and the efficacy of glaucoma filtering surgery is still a major concern for glaucoma surgeons.Therefore, several modifications, combinations, and new techniques of subscleral trabeculectomy have been described.
- In the current study, a fornix-based conjunctival flap will be fashioned in an attempt to encourage more posterior drainage. In this modified trabeculectomy technique, an additional small perpendicular strip of sclera is removed extending from the AC to 2 mm beyond the edge of the scleral flap thus creating an extended subscleral trabeculectomy facilitating aqueous passage into the posterior subconjunctival space.
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)
盲法说明
participants are going to be randomly assigned into two groups outcomes assessor will asses
- visual acuity and BCVA
- IOP using Goldmann applanation tonometry
- slit-lamp and fundus examination of cup-disc ratio,
- Ultrasound Biomicroscopy (UBM) to assese ostium patency and extent of bleb area will be done once after 6 weeks post-operatively.
- Colored photography of the filtering blebs will be performed for grading. Bleb grading will be classified according moorfields grading scale
- Perimetry will be performed at the end of follow up.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with POAG aged from (40- 70) years who are candidate for glaucoma surgery with BCVA ≥ 3/60 to be able to perform visual field testing.
- •Non- compliant patients to the medical treatment willing for follow-up visits for at least 6 months post-operatively .
排除标准
- •Congenital, traumatic, neovascular, uveitic glaucomas or cases with angle closure glaucoma (ACG) associated with shallow AC.
- •Undergoing simultaneous cataract surgery.
- •Previous vitreo-retinal surgery including vitrectomy and buckling surgery.
- •Other pre-existing ocular cicatrizing diseases.
- •Corneal abnormality that precluded reliable applanation tonometry.
研究组 & 干预措施
Group (A)
20 eyes of 20 patients of uncontrolled POAG administrated intervention will be subscleral trabeculectomy (SST) single surgeon, using retrobulbar anaesthesia with 2% lidocaine, will be performed in all surgeries. Following insertion of a lid speculum, a 10/0 silk bridle suture is inserted at superior limbus if required. In group (A) a conjunctival incision is made at the limbus to create a fornix-based conjunctival flap. A half thickness scleral flap (4 × 4 mm) are created and dissected into the clear cornea. A cellulose microsponge soaked in 0.3 mg/ml MMC solution (Mitomycin-C) is applied to the under surface of the scleral flap over a wide posterior area for 2 ml
干预措施: SST in group (A) (Procedure)
group (B)
20 eyes of 20 patients of uncontrolled POAG d Administrated intervention will be ESST another longitudinal scleral groove will be created in the center of the deep scleral bed area measured about 1.5 × 6 mm.In both groups, standard trabeculectomy of equal size (two bites aside) is created by a Kelly punch ( 1 mm)
干预措施: trabeculectomy with ESST in group (B) (Procedure)
结局指标
主要结局
change from baseline intraocular pressure at 3 months
时间窗: 3 months postoperatively
mmHg
change from baseline intraocular pressure at first day postoperative
时间窗: day one postoperatively
mmHg
change from baseline intraocular pressure at 4 weeks
时间窗: , 4 weeks.
mmHg
change from baseline intraocular pressure at 6 months
时间窗: 6 months postoperatively
mmHg
change from baseline intraocular pressure at 6 weeks Ultrasound bimicroscopy (UBM)
时间窗: 6 weeks post-operatively.
mm Hg
次要结局
- extent of filtering bleb area by ultrasound of bio-microscopy (UBM)(6 weeks postoperatively)
- change from baseline best corrected visual acuity (BCVA) at 6 months(at the end of 6 months)
研究者
Rehab mahmoud abdelhamid mohamed
assistant lecturer of ophthalmology,ophthalmology department, medical school
Cairo University