Management Steroid Induced Glaucoma

NCT04673201 | Unknown

• 1 other identifier: R.20.11.1083 - 2020/11/20
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Steroid-Induced Glaucoma

Keywords

Steroid induced glaucoma; Trabeculectomy; Trabeculotomy; MMC

Outcome Measures

Primary Outcomes (3)

• Absolute success

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

  4 years

• qualified success

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

  4 years

• Failure

  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)

  4 years

Study Arms (2)

Viscotrabeculotomy group

ACTIVE COMPARATOR

Management of medically uncontrolled steroid induced glaucoma by viscotrabeculomy technique

Procedure: Viscotrabeculotomy Versus trabeculectomy with "MMC"

Trabeculectomy with "MMC" group

ACTIVE COMPARATOR

Management of medically uncontrolled steroid induced glaucoma by trabeculotomy with MMC

Procedure: Viscotrabeculotomy Versus trabeculectomy with "MMC"

Interventions

Viscotrabeculotomy Versus trabeculectomy with "MMC" PROCEDURE

Viscotrabeculotomy involved the creation of a partial thickness scleral flap, followed by localization of Schlemm's canal by radial incisions.High viscosity sodium hyaluronate was injected into Schlemm's canal.Trabeculotomy was completed using the standard metal Harm's trabeculotome.The scleral flap was then secured and conjunctival closure ensued.Trabeculectomy technique involved a creation of a limbal-based conjunctival flap, followed by creation of a half-thickness sclera flap. MMC was applied underneath the conjunctival flap.The procedure was completed with both sclera and conjunctiva closed by 10/0 nylon sutures.

Trabeculectomy with "MMC" group; Viscotrabeculotomy group

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Oher causes and types of glaucoma

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university ophthalmic center

Al Mansurah, Dakahlyia, 35516, Egypt

RECRUITING

Central Study Contacts

Amr M Abdelkader, MD

CONTACT

1004314242; dramrabdelkader@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of ophthalmology

Model Details: Retrospective comparative study

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: December 17, 2020
• Study Start: November 21, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)