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临床试验/CTRI/2026/02/104644
CTRI/2026/02/104644尚未招募不适用

Outcome of Phacoemulsification with Kahook Dual Blade Goniotomy in patients with Glaucoma

Rutvi Yogesh Doshi1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2026年3月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
78
试验地点
1

研究概览

简要总结

This is a retrospective, observational study designed to evaluate the surgical outcome of combined phacoemulsification with Kahook Dual Blade (KDB) goniotomy in patients diagnosed with glaucoma. The study will be conducted in the Department of Ophthalmology, Kasturba Medical College, Manipal and will include 78 eyes of patients aged 40 years and above who underwent the combined procedure from 1st January, 2024 and who have completed a minimum follow-up of 6 months.

The primary objective is to assess the change in intraocular pressure (IOP) from baseline following surgery at 1 month and 6 months postoperatively. The study will also evaluate the reduction in the number of antiglaucoma medications after surgery. Secondary outcomes include improvement in best-corrected visual acuity (BCVA), overall surgical success based on IOP control and medication reduction, and the incidence of intraoperative and postoperative complications.

Data will be collected retrospectively from electronic medical records using a structured data collection proforma. Preoperative variables will include demographic details, type and severity of glaucoma, baseline IOP, BCVA, and number of antiglaucoma medications. Intraoperative details and postoperative outcomes at 1 and 6 months will be recorded. No additional intervention or patient contact will be undertaken as part of this study.

Statistical analysis will be performed using appropriate descriptive and inferential methods. Changes in continuous variables such as IOP and BCVA will be analyzed using paired statistical tests, and categorical variables will be assessed using suitable comparative tests. A p-value of <0.05 will be considered statistically significant.

As this is a retrospective chart review, there is no direct patient involvement or alteration of standard clinical care. Institutional Ethics Committee approval has been obtained prior to data collection, and patient confidentiality will be strictly maintained through anonymization and secure data handling.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed with primary open-angle glaucoma, pseudoexfoliation glaucoma, pigmentary glaucoma, normal tension glaucoma, traumatic glaucoma and combined mechanism glaucoma
  • Underwent Phacoemulsification with intraocular lens implantation with KDB goniotomy from 1st January 2024 in Kasturba Hospital, Manipal by a) Dr. Vijaya Pai H.
  • b) Dr. Neetha K.I.R.
  • Completed 6 months of follow up.

排除标准

  • Past history of previous glaucoma procedures like trabeculectomy, drainage implant, cyclodestruction procedure or minimally invasive glaucoma surgery in the same eye
  • Neovascular or uveitic glaucoma
  • Incomplete records
  • Intraoperative complications requiring additional glaucoma surgery at the time of surgery
  • Underwent additional glaucoma surgery during the 6 months follow up period.

研究者

发起方
Rutvi Yogesh Doshi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vijaya Pai H

Kasturba Medical College, Manipal

研究点 (1)

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