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.
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
- Recruiting
Mansoura university ophthalmic center
Al Mansurah, Dakahlyia, 35516
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.
- Conditions
- Steroid-Induced Glaucoma
- 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 group | Role | What they receive |
|---|---|---|
| Viscotrabeculotomy group | Active comparator | Management of medically uncontrolled steroid induced glaucoma by viscotrabeculomy technique Receives: Procedure: Viscotrabeculotomy Versus trabeculectomy with "MMC" |
| Trabeculectomy with "MMC" group | Active comparator | Management 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.
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
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
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.
- First posted17 Dec 2020
- Study start21 Nov 2020
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid-Induced GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohammed Elsayed Abdelkader, Mansoura University
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viscotrabeculotomy Versus Trabeculectomy With "MMC" for the Management of Medically Uncontrolled Steroid Induced Glaucoma
- ClinicalTrials.gov ID
- NCT04673201
- Acronym / sponsor ID
- R.20.11.1083 - 2020/11/20
- Conditions
- Steroid-Induced Glaucoma
- Keywords
- Steroid induced glaucoma, Trabeculectomy, Trabeculotomy, MMC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 Nov 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Retrospective comparative study
| Arm | Type | Receives |
|---|---|---|
| Viscotrabeculotomy group | Active comparator | Procedure: Viscotrabeculotomy Versus trabeculectomy with "MMC"Management of medically uncontrolled steroid induced glaucoma by viscotrabeculomy technique |
| Trabeculectomy with "MMC" group | Active comparator | Procedure: Viscotrabeculotomy Versus trabeculectomy with "MMC"Management of medically uncontrolled steroid induced glaucoma by trabeculotomy with MMC |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Oher causes and types of glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viscotrabeculotomy Versus trabeculectomy with "MMC"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. | Procedure or surgery | Trabeculectomy with "MMC" group, Viscotrabeculotomy group |
Primary outcome
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,
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,
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.