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临床试验/NCT05666440
NCT05666440尚未招募不适用

Visco-Circumferential-Suture-Trabeculotomy Versus Rigid Probe Viscotrabeculotomy in Primary Open Angle Glaucoma

Mansoura University0 个研究点目标入组 166 人开始时间: 2023年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
166
主要终点
BCVA

研究概览

简要总结

Visco-Circumferential-Suture-Trabeculotomy versus Rigid probe Viscotrabeculotomy in Primary Open Angle Glaucoma.

详细描述

Introduction Glaucoma is the leading cause of irreversible visual loss worldwide. Primary open angle glaucoma (POAG) is the most common type of glaucoma accounting for 74% of all glaucoma cases (1, 2). Trabeculectomy is still the most commonly performed glaucoma surgery worldwide (3). However, trabeculectomy has several vision-threatening complications as ocular hypotony, choroidal detachment and bleb related infections (4). Therefore, in the recent years, bleb independent less invasive procedures as canaloplasty (5,6), gonioscopy-assisted transluminal trabeculotomy (GATT) (7,8) and ab externo circumferential trabeculotomy (6,9) have become increasingly popular because of their great efficacy and excellent safety profile. Despite the successful outcomes and the few postoperative complications of GATT in juvenile and adult POAG, however on the downside, surgeons with less experience performing GATT procedure may initially struggle with it. Also, GATT requires a goniolens and a reasonably clear cornea to visualize the nasal angle. Introducing instruments into the anterior chamber also poses an increased risk for damage to intraocular structures (10, 11). Looking at ab externo trabeculotomy, for many years, many authors have demonstrated its efficacy in lowering IOP in congenital (12, 13, 14), juvenile (15, 16) and adult open angle glaucomas (6, 9, 17). Trabeculotomy ab externo techniques include conventional probe trabeculotomy, viscotrabeculotomy (VT) (17), 360 - degree suture trabeculotomy (9) , viscocircumferential -suture trabeculotomy (VCST) (14) and trabeculotomy with the use of illuminated microcatheter.(15,18). Although the illuminated microcatheter helps to cannulate SC safely, however its cost constitutes a financial burden in many countries. VCST was proved to be effective for reduction of IOP in PCG as it offers the advantages of performing 360 circumferential trabeculotomy with a great ease and a low cost (14). The aim of the present study was to compare the surgical outcomes of (VCST) and rigid probe VT in patients with POAG.

Purpose:

This study aims to compare the surgical outcomes of (VCST) and rigid probe VT in patients with POAG.

Methods:

The study is conducted at Mansoura university ophthalmic Center. Sample size has been calculated using Cochran's formula with a 95% confidence level and Z value of 1.95. This comparative study was conducted on 166 eyes of 107 patients with medically uncontrolled primary open-angle glaucoma diagnosed and operated upon in the Mansoura Ophthalmic Center of Mansoura University, Egypt between February 2017 and December 2020. The study follows the tenets of the Declaration of Helsinki. All patients of the study received a clear explanation of the study design, the surgical procedures and their possible consequences and they gave written informed consent.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The diagnosis of OAG was based on the optic nerve head appearance typical to glaucoma (increased optic disc cupping, thinning of the neuro-retinal rim, focal notching, splinter haemorrhage), corresponding visual feld loss typical to glaucoma coupled with an elevated IOP above the statistical normal of 21 mmHg and a gonioscopically open angle in the absence of any known cause for glaucoma. IOP-lowering medications were initiated for all patients and only those patients in whom control of the disease failed (as evidenced by progressive optic nerve damage and/or visual feld deterioration) and the decision for surgical intervention to lower the IOP was taken were enrolled in the study. Adult patients (above 18 years of age) fulflling these criteria were enrolled

排除标准

  • Other types of glaucomas and co-morbidities

结局指标

主要结局

BCVA

时间窗: 2 years

The primary outcome measure was the IOP

时间窗: 2 years

Success was defned as \[15\] an IOP ≤ 18 mmHg (criteria 1), an IOP ≤ 16 mmHg (criteria 2), IOP ≤ 14 mmHg (criteria 3) and ≤ 12 mmHg (criteria 4) and/or IOP reduction by ≥ 30% of baseline IOP (last IOP measurement immediately before surgery) without IOP lowering medications (complete success) (qualifed success was defned as IOP controlled according to the same criteria with/without IOP lowering medications), without the need for further surgery for IOP reduction and without any vision threatening complications or hypotony (IOP ≤ 5 mmHg).

number of IOP lowering medications.

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Mohammed Elsayed Abdelkader

Assisstant professor of ophthalmology

Mansoura University

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