Prospective Study To Evaluate The Safety And Efficacy Of ICath Device In Illuminated Microcatheter Assisted Transluminal Trabeculotomy (iMAT) Versus Combined Trabeculotomy And Trabeculectomy In Patients With Primary Congenital Glaucoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Aurolab
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- 1 IOP
研究概览
简要总结
The most common cause of glaucoma in the pediatric population is primary congenital glaucoma (PCG) which can have devasting visual consequences.The management is surgical and to create fluid outflow pathway by surgeries including goniotomy and trabeculotomy or trabeculectomy. Specifically in cases of hazy corneas, combined trabeculotomy with trabeculectomy ab externo is the preferred initial surgery
Illuminated microcatheter assisted trabeculotomy has emerged as a good surgical alternative with improved success rates compared to conventional CTT. The lighted tip to guide the catheter minimizes potentially devasting inadvertent misdirection into the suprachoroidal or subretinal space by verification of the microcatheter location within Schlemm’s canal.
The purpose of this study is to evaluate the safety and efficacy of ICath device for Illuminated Microcatheter Assisted Transluminal Trabeculotomy (iMAT) and compare with Combined Trabeculotomy and Trabeculectomy in patients with Primary Congenital Glaucoma.
The objective of the study is to evaluate the safety and efficacy of I Cath device using Illuminated Microcatheter Assisted Transluminal Trabeculotomy (iMAT) compared Combined Trabeculotomy and Trabeculectomy in patients with Primary Congenital Glaucoma. The study will include treatment Naïve PCG children, with no central corneal scar or cleft and corneal diameter not greater than 13 mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Day(s) 至 3.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Age between 15 days to 3 years (surgery will be performed as per physician fitness) 2 Typical Primary Congenital Glaucoma with grade 1 to 4 corneal haze 3 Parents of the patient is willing and able to comply with study procedures and sign informed consent.
排除标准
- •1 PCG operated earlier 2 PCG with central cleft or grade 5 corneal haze 3 PCG with HCD greater than 13 mm at the time of surgery 4 Patients with any other types of secondary glaucoma 5 Patients with any other ocular diseases.
- •6 Not willing to participate or come for follow up.
结局指标
主要结局
1 IOP
时间窗: Pre op | Post operative day 1 | Post operative day 15 or 1 month | Post operative day 3 months | Post operative day 6 months | Post operative day 8 months | Post operative day 1 year
2 Ocular examination
时间窗: Pre op | Post operative day 1 | Post operative day 15 or 1 month | Post operative day 3 months | Post operative day 6 months | Post operative day 8 months | Post operative day 1 year
3 Minimal or no anti glaucoma medication
时间窗: Pre op | Post operative day 1 | Post operative day 15 or 1 month | Post operative day 3 months | Post operative day 6 months | Post operative day 8 months | Post operative day 1 year
4 Stable AL and refractive error
时间窗: Pre op | Post operative day 1 | Post operative day 15 or 1 month | Post operative day 3 months | Post operative day 6 months | Post operative day 8 months | Post operative day 1 year
5 Complications
时间窗: Pre op | Post operative day 1 | Post operative day 15 or 1 month | Post operative day 3 months | Post operative day 6 months | Post operative day 8 months | Post operative day 1 year
次要结局
未报告次要终点
