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Steroid-Induced GlaucomaNCT04673201

Management Steroid Induced Glaucoma

A study testing Viscotrabeculotomy Versus trabeculectomy with "MMC" in people with Steroid-Induced Glaucoma, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Steroid-Induced Glaucoma
What is being tested?
Viscotrabeculotomy Versus trabeculectomy with "MMC"
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteEgypt
Study dates
21 Nov 2020to Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Oher causes and types of glaucoma

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Mansoura university ophthalmic center

    Al Mansurah, Dakahlyia, 35516

    Recruiting

Other trials in Egypt

About this study

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

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.

Read the 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.

Viscotrabeculotomy (VT) performed in this study involved the creation of a partial thickness (about 50% thickness) quadrangular (4x4 mm) scleral flap, followed by localization of Schlemm's canal by radial incisions straddling the limbus. High viscosity sodium hyaluronate (Healon GV, Pfizer, NY, USA) was then slowly injected into both ends of Schlemm's canal. Trabeculotomy was completed using the standard metal Harm's trabeculotome (Geuder Instruments, Heidelberg, Germany). Rotation of these probes achieved 120-degree opening of the trabecular meshwork. Next, a small amount of sodium hyaluronate was injected through the open ends of the canal of Schlemm and along the trabeculotomy openings. The scleral flap was then secured tightly with interrupted 10/0 Nylon sutures and conjunctival closure ensued.

Trabeculectomy technique involved a creation of a limbal-based conjunctival flap, followed by creation of a 3 x 4 rectangular half-thickness sclera flap. MMC was applied in a concentration of 0.03% for 3 minutes through soaked surgical sponge inserted underneath the conjunctival flap and spread of a large surface area posterior to the limbus and planned scleral flap site then thoroughly irrigated by 200mL of sterile normal saline. The procedure was completed in the usual manner with both sclera and conjunctiva closed by 10/0 nylon sutures. Postoperative treatment for both groups consisted of topical steroids (dexamethasone) and antibiotic (ofloxacin) five times a day with gradual taper over a period of 5 weeks.

Surgical success was defined at the end of the 4 years of follow up as an IOP between 6 and 21 mmHg and /or IOP reduction greater than 35 % of baseline throughout the entire follow-up period. Absolute success was defined as success being achieved without medications, and qualified success was defined as achieving success with adjunctive medications. Failure was defined as 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). A minimum follow-up of 3 years was required for inclusion in the study.

During the follow up period, eyes that were labelled as "Failure" at any follow up time point were excluded from the data analysis from that follow up time point to the end of the study period (48 months). Follow up was maintained to the patient as part of the patient care service routinely provided by the study setting. The patients' postoperative data was collected from records at day 1, week 1, month 1, month 3, month 6, month 12, month 18, month 24, month 30, month 36 and month 48.

Being tested
Viscotrabeculotomy Versus trabeculectomy with "MMC"
Keywords
Steroid induced glaucoma, Trabeculectomy, Trabeculotomy, MMC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Viscotrabeculotomy Versus trabeculectomy with "MMC"Procedure or surgery

    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.

Study groups in NCT04673201
Study groupRoleWhat they receive
Viscotrabeculotomy groupActive comparatorManagement of medically uncontrolled steroid induced glaucoma by viscotrabeculomy technique
Receives: Procedure: Viscotrabeculotomy Versus trabeculectomy with "MMC"
Trabeculectomy with "MMC" groupActive comparatorManagement of medically uncontrolled steroid induced glaucoma by trabeculotomy with MMC
Receives: Procedure: Viscotrabeculotomy Versus trabeculectomy with "MMC"

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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,

    Measured: 4 years

  2. 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,

    Measured: 4 years

  3. 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)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start21 Nov 2020
  3. Primary completionApr 2021 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Retrospective comparative study
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673201
Sponsor's protocol ID
R.20.11.1083 - 2020/11/20
Status last verified
Dec 2020
First submitted
12 Dec 2020
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Viscotrabeculotomy Versus trabeculectomy with "MMC" in people with Steroid-Induced Glaucoma, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amr M Abdelkader, MD (1004314242 ext. +20, dramrabdelkader@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute success (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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