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Clinical Trials/NCT04673201
NCT04673201UnknownNot Applicable

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

Mansoura University2 sites in 1 country86 target enrollmentStarted: November 21, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
86
Locations
2
Primary Endpoint
Absolute success

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Years to 70 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • Oher causes and types of glaucoma

Outcomes

Primary Outcomes

Absolute success

Time Frame: 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

Time Frame: 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

Time Frame: 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,

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amr Mohammed Elsayed Abdelkader

Lecturer of ophthalmology

Mansoura University

Study Sites (2)

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