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临床试验/NCT04673201
NCT04673201Unknown不适用

Viscotrabeculotomy Versus Trabeculectomy With "MMC" for the Management of Medically Uncontrolled Steroid Induced Glaucoma

Mansoura University2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2020年11月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
86
试验地点
2
主要终点
Absolute success

研究概览

简要总结

Purpose:

To assess the safety and efficacy of Viscotrabeculotomy Versus trabeculectomy with MMC for the management of medically uncontrolled steroid induced glaucoma.

Patients and methods:

A retrospective review of 86 eyes of 67 patients with medically uncontrolled SIG who underwent either viscotrabeculotomy (VT) or trabeculectomy with MMC (Trab-MMC) at Mansoura Ophthalmic Center (Mansoura, Egypt) between January 2008, and December 2017 was conducted.

Keywords:

Steroid induced glaucoma, trabeculectomy, trabeculotomy and MMC.

详细描述

Introduction:

Steroid induced glaucoma(SIG) is a form of open-angle glaucoma associated with various modalities of corticosteroid administration such as oral, intravenous, inhaled, ocular instilled, intravitreal, and periocular u.Some histologic studies have reported the accumulation of extracellular matrices including basement membrane-like material, fine fibrillar-like material or proteoglycans in the trabecular meshwork (TM) of SIG patients. These observations suggest that such accumulation could lead to an increased resistance to aqueous outflow in the TM of SIG patients.Surgical procedures for intraocular pressure (IOP) reduction in eyes with SIG include trabeculectomy, trabeculotomy,viscocanalostomy and laser trabeculoplasty. Although several case series have shown that these surgeries are effective for IOP reduction, surgical outcomes for SIG are not fully understood due to lack of large case-control studies aiming to investigate the success rates of trabeculotomy in SIG eyes.It has previously been reported that trabeculotomy more effectively reduces IOP in adult Japanese patients with exfoliative glaucoma than in primary open-angle glaucoma (POAG).This IOP lowering effect in eyes with exfoliative glaucoma is thought to be attributable to the relief of abnormally increased outflow resistance that was induced by the accumulation of exfoliative material within the TM. For the same reason, trabeculotomy has been the surgical procedure of choice for adult patients with SIG among Japanese surgeons.Honjo etal previously showed that trabeculotomy helped to reduce IOPs to 21 mm Hg or less in 14 Japanese patients with SIG. However, some questions still without answers for example, whether trabeculotomy with its modifications for SIG offers better IOP management than other surgeries such as trabeculectomy with mitomycin C (MMC), or which characteristics of patients with SIG show better prognosis after trabeculotomy. Therefore the purpose of this retrospective study was to compare the long term surgical outcomes of viscotrabeculectomy(VT) and trabeculectomy with mitomycin C (Trab-MMC) in patients with uncontrolled steroid induced glaucoma.

Subjects and methods:

A retrospective review of 86 eyes of 67 patients with medically uncontrolled SIG who underwent either viscotrabeculotomy (VT) or trabeculectomy with MMC (Trab-MMC) at Mansoura Ophthalmic Center (Mansoura, Egypt) between January 2008, and December 2017 was conducted. The research conformed to the provisions of the Declaration of Helsinki. The confidentiality of the data was ensured. The VT group included 45 eyes and the Trab-ologen group included 41 eyes.

Demographic and clinical data were retrieved from the records such as age at surgery, gender, best-corrected visual acuity (BCVA, LogMAR), intraocular pressure (IOP), gonioscopy, number of glaucoma medications, surgical details and postoperative complications. Steroid-induced glaucoma eyes were defined as open-angle eyes with an IOP elevation of 22 mm Hg or more after the administration of corticosteroid. Glaucoma surgery was performed when IOP was persistently elevated despite maximal tolerated IOP-lowering therapy with potential or actual compromise of optic nerve structure (progressive optic nerve cupping) and/or function (deterioration of visual field testing). All patients were required to sign informed consent forms before surgery.

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
2 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eyes with steroid induced glaucoma when IOP was persistently elevated despite maximal tolerated IOP-lowering therapy with potential or actual compromise of optic nerve structure (progressive optic nerve cupping) and/or function (deterioration of visual field testing)
  • A minimum follow-up of 3 years was required for inclusion in the study

排除标准

  • Oher causes and types of glaucoma

结局指标

主要结局

Absolute success

时间窗: 4 years

an IOP between 6 and 21 mmHg and /or IOP reduction greater than 35 % of baseline throughout the entire follow-up period without medications,

Failure

时间窗: 4 years

not meeting the above criteria, or any return to the operating theatre for glaucoma reoperation, or loss of vision to no light perception or hypotony (IOP \<6 mmHg on 2 occasions after 3 months from the operation)

qualified success

时间窗: 4 years

an IOP between 6 and 21 mmHg and /or IOP reduction greater than 35 % of baseline throughout the entire follow-up period with medications,

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

Lecturer of ophthalmology

Mansoura University

研究点 (2)

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