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临床试验/CTRI/2025/09/094915
CTRI/2025/09/094915尚未招募3 期

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

Aurolab2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年10月1日最近更新:

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

研究者

发起方
Aurolab
申办方类型
Other [trust]
责任方
Principal Investigator
主要研究者

Dr Srisha Senthil

LV Prasad Eye Institute

研究点 (2)

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