Randomized Controlled Study to Evaluate Safety and Efficacy of Ologen® Collagen Matrix in Patients With Primary Congenital Glaucoma Undergoing Trabeculectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Comparing IOP control between the two groups:Change of intraocular pressure (IOP) over time
研究概览
简要总结
To the best of Investigator knowledge, no studies to this date have compared the safety and efficacy of ologen® Collagen Matrix in Primary congenital glaucoma (PCG) patients undergoing trabeculectomy. Given that filtration surgery is usually less successful in patients with developmental glaucoma; the purpose of this study is to compare combined trabeculectomy with trabeculotomy (CTT) with adjuvant ologen® Collagen Matrix versus CTT without ologen® in children with PCG. Investigator hypothesis is that CTT with ologen® Collagen Matrix would be as effective as CTT in IOP control, but with reduced scarring and long term healthier bleb morphology.
详细描述
Standard combined trabeculectomy with trabeculotomy (CTT) All CTT surgeries will be performed under general anesthesia.Under aseptic surgical technique, a superior rectus suture will be placed using 4'0 silk and a limbal-based conjunctival flap to be performed. Sub-Tenon dissection and hemostasis will be achieved and a half-thickness 4 x 4mm rectangular scleralflap will to be dissected up to clear cornea, and radial incision will be placed at the location of the schemes canal, Harms trabepculotome will be used to pass into the schemes canal and rotated into the anterior chamber to open app 60 degree on either sides, A 2 × 2 mm deep scleral block will be excised and peripheral iridectomy will be performed. The scleral flap will be closed with one 10-0 nylon suture and conjunctiva will be closed with 8-0 vicryl continuous suture.
The same procedure will be done for the CTT with ologen® except, before closing the conjunctiva, the ologen® implant will be placed subconjunctivally just overlapping the apex of the triangular scleral flap
ologen® Collagen Matrix ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 (valid till Mar-15-2018) will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.
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, Investigator)
盲法说明
Eligible patient after screening will be assigned consecutive randomization numbers in ascending order upon enrollment. The patient will be randomized in 1:1ratio to one of two study groups, namely combined trabeculotomy with trabeculectomy with ologen® Collagen Matrix as adjunctive wound modulator(Group A) or combined trabeculotomy with trabeculectomy alone without any adjunctive (Group B). The assigned randomization number will be recorded in each subject's DCF. The randomization scheme will be generated using random function in excel before patient enrollment in order to avoid investigator's patient selection bias.
入排标准
- 年龄范围
- 1 Month 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 1 month to 3 years (inclusive)
- •Any case diagnosed as congenital glaucoma (with enlarged corneal diameter more than 11 mm, including corneal edema or Haab'sstria with or without optic disc cupping, IOP>12 mm Hg)
- •Parents of the patientis willing and able to comply with study procedures and sign informed consent
排除标准
- •Patients withany other types of secondary glaucoma
- •Patients with any other ocular disease
结局指标
主要结局
Comparing IOP control between the two groups:Change of intraocular pressure (IOP) over time
时间窗: 12 months
Assess control of IOP over time. "Complete success" is defined as IOP reduction of \>20% and / or an IOP constantly \<21 mmHg without any antiglaucoma medication. "Qualified success" is defined as IOP \< 21 mmHg with topical antiglaucoma medication. "Failure" is defined as IOP \> 21mmHg in 2 subsequent follow visits despite topical antiglaucoma medication.
次要结局
- Comparing bleb morphology in two groups by change of Moorfields Bleb Grading System (MBGS) score over time(12 months)
研究者
HERF
Consultant-Ophthalmologist
L.V. Prasad Eye Institute