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临床试验/CTRI/2026/01/102113
CTRI/2026/01/102113尚未招募不适用

EFFICACY AND SAFETY OF KAHOOK DUAL BLADE GONIOTOMY IN OPEN ANGLE GLAUCOMA PATIENTS: A PROSPECTIVE STUDY

Nethradhama Super Speciality Eye Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1

研究概览

简要总结

SURGICAL TECHNIQUE

The KDB tip enters the anterior chamber through a temporal peripheral clear corneal incision and advanced to the nasal TM under direct gonioscopic visualization. The instrument’s sharp tip then engages TM, fashioning an opening through which heel at the base of footplate is seated in schlemm’s canal. Then, the tip is advanced within the canal along with TM, which is elevated onto the ramp and stretched as it is guided to two cutting blades that remove an intact TM strip. The strip is removed from the eye with KDB or with forceps. This elevation and stretching of the TM before excision maximizes the width of excised strip and protects adjacent structures from collateral injury.

STUDY POPULATION: Patients diagnosed with mild to moderate stage open angle glaucoma undergoing KDB goniotomy as a standalone or combined with phacoemulsification visiting the Glaucoma department of Nethradhama Super speciality Eye Hospital, Jayanagar, Karnataka willing to participate in the study.

METHODOLOGY

The study will be conducted after approval by the institutional review board of Nethradhama Superspeciality Eye Hospital, Bangalore and will adhere to the tenets of declaration of Helsinki.

Procedure:

After obtaining informed consent from the patients enrolled in the study, baseline data including glaucoma type and severity, preoperative IOP, number of antiglaucoma medication [AGM] will be recorded. All surgeries will be performed by a single surgeon. Operative details will be noted. Patients will be followed up at 1 day, 1 week, 1, 3 and 6 months postoperatively. Safety will be assessed in terms of complications of the procedure. Success criteria are defined based on 20% IOP reduction or >/= 1 AGM reduction.

Excisional goniotomy is generally a safe procedure without significant sight-threatening complications. Transient bleeding from the TM excision site is common and typical of most angle based surgeries. The most common complications associated with excisional goniotomy are elevated intraocular pressure [3-32%], posterior capsule opacification [combined surgery][ 9%], transient pain [8%].

Unlike other glaucoma procedures, it does not require the implantation of a device, obviating secondary surgical procedures for device-related complications, and does not create a bleb, precluding the need for suture lysis, needling, and other postoperative bleb management procedures. Reoperation rate due to surgical failure is 2-22%, higher rates in patients with more severe glaucoma and/or higher baseline IOP.

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
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with mild to moderate stage glaucoma Patients with a diagnosis of ocular hypertension, primary open angle glaucoma Patients with secondary open angle glaucoma [pseudoexfoliative, pigmentary glaucoma].

排除标准

  • Patients with angle closure glaucoma • Poor visualization of angles due to media haze • Active uveitis • Neovascular glaucoma • Patients with advanced stage glaucoma.

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr KOMMINENI SINDUSHA

Nethradhama Super Speciality Eye Hospital

研究点 (1)

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