Primary Open-angle GlaucomaPOAGNCT03480711

Modified Trabeculectomy With an ESST Versus Conventional SST for Management of Primary Open Angle Glaucoma

A study testing SST in group (A) and trabeculectomy with ESST in group (B) in people with Primary Open-angle Glaucoma, run by Rehab mahmoud abdelhamid mohamed at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate prospectively the surgical outcome in terms of intraocular pressure control, potential advantages, disadvantages, success rate, complications and bleb morphology of this modified trabeculectomy with an extended subscleral tunnel (ESST) in comparison to the conventional subscleral trabeculectomy (SST) in… Read more about this study

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Primary Open-angle Glaucoma
What is being tested?: SST in group (A) and trabeculectomy with ESST in group (B)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteEgypt
Study dates: 10 Jul 2018to 2 Mar 2019
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 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with POAG aged from (40- 70) years who are candidate for glaucoma surgery with BCVA ≥ 3/60 to be able to perform visual field testing.
Non- compliant patients to the medical treatment willing for follow-up visits for at least 6 months post-operatively .

Who cannot join

Congenital, traumatic, neovascular, uveitic glaucomas or cases with angle closure glaucoma (ACG) associated with shallow AC.
Undergoing simultaneous cataract surgery.
Previous vitreo-retinal surgery including vitrectomy and buckling surgery.
Other pre-existing ocular cicatrizing diseases.
Corneal abnormality that precluded reliable applanation tonometry.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of medicind
Cairo

Other trials in Egypt

About this study

Official title: Modified Trabeculectomy With an Extended Subscleral Tunnel Versus Conventional Trabeculectomy for Management of Primary Open Angle Glaucoma (POAG)

To evaluate prospectively the surgical outcome in terms of intraocular pressure control, potential advantages, disadvantages, success rate, complications and bleb morphology of this modified trabeculectomy with an extended subscleral tunnel (ESST) in comparison to the conventional subscleral trabeculectomy (SST) in management of uncontrolled primary open angle glaucoma.
This study will recruit 40 eyes of (40) candidate patients with primary open angle glaucoma (POAG) who are indicated for surgery.
The candidate patients will be recruited into 2 equal comparative groups. In group (A) 20 eyes (20 patients) who will undergo conventional (SST) with intraoperative mitomycin C (MMC) (0.03%) and group (B); 20 eyes of 20 patients will undergo trabeculectomy with an ESST also with intraoperative adjunctive MMC (0.03%).

Read the detailed description

Different surgical procedures were developed and the principle behind them was to establish a fistula between the anterior chamber and the subconjunctival space to permit the aqueous humour to exit the eye.
Subscleral trabeculectomy has remained the most commonly performed glaucoma surgery to which the newer operations are compared.Although this procedure is very effective in reducing intraocular pressure (IOP) immediately, surgical failure has often been observed over time due to fibrosis of the surgical site and resultant non-filtering bleb. -Improvement of the complication profile and the efficacy of glaucoma filtering surgery is still a major concern for glaucoma surgeons.Therefore, several modifications, combinations, and new techniques of subscleral trabeculectomy have been described.
In the current study, a fornix-based conjunctival flap will be fashioned in an attempt to encourage more posterior drainage. In this modified trabeculectomy technique, an additional small perpendicular strip of sclera is removed extending from the AC to 2 mm beyond the edge of the scleral flap thus creating an extended subscleral trabeculectomy facilitating aqueous passage into the posterior subconjunctival space.

Conditions: Primary Open-angle Glaucoma
Being tested: SST in group (A), trabeculectomy with ESST in group (B)
Keywords: subscleral trabeculectomy, extended subscleral tunnel, mitomycinC
Medical subject headings: Glaucoma, Open-Angle

What participants receive

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

SST in group (A)Procedure or surgery
Also called subscleral trabeculectomy, conventional trabeculectomy
group (A) single surgeon, using retrobulbar anaesthesia with 2% lidocaine, will be performed in all surgeries. Following insertion of a lid speculum, a 10/0 silk bridle suture is inserted at superior limbus if required. In group (A) a conjunctival incision is made at the limbus to create a fornix-based conjunctival flap. A half thickness scleral flap (4 × 4 mm) are created and dissected into the clear cornea. A cellulose microsponge soaked in 0.3 mg/ml MMC solution (Mitomycin-C) is applied to the under surface of the scleral flap over a wide posterior area for 2 ml
trabeculectomy with ESST in group (B)Procedure or surgery
Also called modified trabeculectomy, extended subscleral tunnel
group (B), another longitudinal scleral groove will be created in the center of the deep scleral bed area measured about 1.5 × 6 mm.In both groups, standard trabeculectomy of equal size (two bites aside) is created by a Kelly punch ( 1 mm)

Study groups in NCT03480711
Study group	Role	What they receive
Group (A)	Experimental	20 eyes of 20 patients of uncontrolled POAG administrated intervention will be subscleral trabeculectomy (SST) single surgeon, using retrobulbar anaesthesia with 2% lidocaine, will be performed in all surgeries. Following insertion of a lid speculum, a 10/0 silk bridle suture is inserted at superior limbus if required. In group (A) a conjunctival incision is made at the limbus to create a fornix-based conjunctival flap. A half thickness scleral flap (4 × 4 mm) are created and dissected into the clear cornea. A cellulose microsponge soaked in 0.3 mg/ml MMC solution (Mitomycin-C) is applied to the under surface of the scleral flap over a wide posterior area for 2 ml Receives: Procedure: SST in group (A)
group (B)	Experimental	20 eyes of 20 patients of uncontrolled POAG d Administrated intervention will be ESST another longitudinal scleral groove will be created in the center of the deep scleral bed area measured about 1.5 × 6 mm.In both groups, standard trabeculectomy of equal size (two bites aside) is created by a Kelly punch ( 1 mm) Receives: Procedure: trabeculectomy with ESST in group (B)

What is being measured

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

change from baseline intraocular pressure at first day postoperative
mmHg
Measured: day one postoperatively
change from baseline intraocular pressure at 4 weeks
mmHg
Measured: , 4 weeks.
change from baseline intraocular pressure at 6 weeks Ultrasound bimicroscopy (UBM)
mm Hg
Measured: 6 weeks post-operatively.
change from baseline intraocular pressure at 3 months
mmHg
Measured: 3 months postoperatively
change from baseline intraocular pressure at 6 months
mmHg
Measured: 6 months postoperatively

Secondary outcomes (2)

change from baseline best corrected visual acuity (BCVA) at 6 months
logarithm of minimal angle of resolution (log MAR)
Measured: at the end of 6 months
extent of filtering bleb area by ultrasound of bio-microscopy (UBM)
width, depth and height of filtering bleb area in millimeter
Measured: 6 weeks postoperatively

Timeline

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

10 Jul 20182 Mar 2019

First posted29 Mar 2018
Study start10 Jul 2018
Primary completion28 Feb 2019
Study completion2 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Primary Open-angle 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: Randomised
Intervention model: Parallel groups
Model description: Randomized non-controlled comparative prospective interventional study
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03480711
Sponsor's protocol ID: N-38-2018
Acronym: POAG
Status last verified: Jul 2022
First submitted: 15 Mar 2018
Last updated: 19 Jul 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: study protocol Statistical analysis plan within 6 months after completing the study

Publications

El Sayyad F, Belmekki M, Helal M, Khalil M, El-Hamzawey H, Hisham M. Simultaneous subconjunctival and subscleral mitomycin-C application in trabeculectomy. Ophthalmology. 2000 Feb;107(2):298-301; discussion 302. doi: 10.1016/s0161-6420(99)00097-4.
PubMed 10690829
Nuijts RM, Vernimmen RC, Webers CA. Mitomycin C primary trabeculectomy in primary glaucoma of white patients. J Glaucoma. 1997 Oct;6(5):293-7.
PubMed 9327347

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Open-angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modified Trabeculectomy With an Extended Subscleral Tunnel Versus Conventional Trabeculectomy for Management of Primary Open Angle Glaucoma (POAG)
ClinicalTrials.gov ID: NCT03480711
Acronym / sponsor ID: POAG / N-38-2018
Conditions: Primary Open-angle Glaucoma
Keywords: subscleral trabeculectomy, extended subscleral tunnel, mitomycinC
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Rehab mahmoud abdelhamid mohamedUniversity, hospital or other
Collaborators: Cairo University
Study start: 10 Jul 2018 (actual)
Primary completion: 28 Feb 2019 (actual)
Study completion: 2 Mar 2019 (actual)
First posted: 29 Mar 2018 (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.

To evaluate prospectively the surgical outcome in terms of intraocular pressure control, potential advantages, disadvantages, success rate, complications and bleb morphology of this modified trabeculectomy with an extended subscleral tunnel (ESST) in comparison to the conventional subscleral trabeculectomy (SST) in management of uncontrolled primary open angle glaucoma.
This study will recruit 40 eyes of (40) candidate patients with primary open angle glaucoma (POAG) who are indicated for surgery.
The candidate patients will be recruited into 2 equal comparative groups. In group (A) 20 eyes (20 patients) who will undergo conventional (SST) with intraoperative mitomycin C (MMC) (0.03%) and group (B); 20 eyes of 20 patients will undergo trabeculectomy with an ESST also with intraoperative adjunctive MMC (0.03%).

Detailed description

Different surgical procedures were developed and the principle behind them was to establish a fistula between the anterior chamber and the subconjunctival space to permit the aqueous humour to exit the eye.
Subscleral trabeculectomy has remained the most commonly performed glaucoma surgery to which the newer operations are compared.Although this procedure is very effective in reducing intraocular pressure (IOP) immediately, surgical failure has often been observed over time due to fibrosis of the surgical site and resultant non-filtering bleb. -Improvement of the complication profile and the efficacy of glaucoma filtering surgery is still a major concern for glaucoma surgeons.Therefore, several modifications, combinations, and new techniques of subscleral trabeculectomy have been described.
In the current study, a fornix-based conjunctival flap will be fashioned in an attempt to encourage more posterior drainage. In this modified trabeculectomy technique, an additional small perpendicular strip of sclera is removed extending from the AC to 2 mm beyond the edge of the scleral flap thus creating an extended subscleral trabeculectomy facilitating aqueous passage into the posterior subconjunctival space.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Randomized non-controlled comparative prospective interventional study

Arm	Type	Receives
Group (A)	Experimental	Procedure: SST in group (A)20 eyes of 20 patients of uncontrolled POAG administrated intervention will be subscleral trabeculectomy (SST) single surgeon, using retrobulbar anaesthesia with 2% lidocaine, will be performed in all surgeries. Following insertion of a lid speculum, a 10/0 silk bridle suture is inserted at superior limbus if required. In group (A) a conjunctival incision is made at the limbus to create a fornix-based conjunctival flap. A half thickness scleral flap (4 × 4 mm) are created and dissected into the clear cornea. A cellulose microsponge soaked in 0.3 mg/ml MMC solution (Mitomycin-C) is applied to the under surface of the scleral flap over a wide posterior area for 2 ml
group (B)	Experimental	Procedure: trabeculectomy with ESST in group (B)20 eyes of 20 patients of uncontrolled POAG d Administrated intervention will be ESST another longitudinal scleral groove will be created in the center of the deep scleral bed area measured about 1.5 × 6 mm.In both groups, standard trabeculectomy of equal size (two bites aside) is created by a Kelly punch ( 1 mm)

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with POAG aged from (40- 70) years who are candidate for glaucoma surgery with BCVA ≥ 3/60 to be able to perform visual field testing.
Non- compliant patients to the medical treatment willing for follow-up visits for at least 6 months post-operatively .

Key exclusion criteria (5 listed)

Congenital, traumatic, neovascular, uveitic glaucomas or cases with angle closure glaucoma (ACG) associated with shallow AC.
Undergoing simultaneous cataract surgery.
Previous vitreo-retinal surgery including vitrectomy and buckling surgery.
Other pre-existing ocular cicatrizing diseases.
Corneal abnormality that precluded reliable applanation tonometry.

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
SST in group (A)Also: subscleral trabeculectomy, conventional trabeculectomygroup (A) single surgeon, using retrobulbar anaesthesia with 2% lidocaine, will be performed in all surgeries. Following insertion of a lid speculum, a 10/0 silk bridle suture is inserted at superior limbus if required. In group (A) a conjunctival incision is made at the limbus to create a fornix-based conjunctival flap. A half thickness scleral flap (4 × 4 mm) are created and dissected into the clear cornea. A cellulose microsponge soaked in 0.3 mg/ml MMC solution (Mitomycin-C) is applied to the under surface of the scleral flap over a wide posterior area for 2 ml	Procedure or surgery	Group (A)
trabeculectomy with ESST in group (B)Also: modified trabeculectomy, extended subscleral tunnelgroup (B), another longitudinal scleral groove will be created in the center of the deep scleral bed area measured about 1.5 × 6 mm.In both groups, standard trabeculectomy of equal size (two bites aside) is created by a Kelly punch ( 1 mm)	Procedure or surgery	group (B)

Primary outcome

change from baseline intraocular pressure at first day postoperative
Time frame: day one postoperatively
mmHg
change from baseline intraocular pressure at 4 weeks
Time frame: , 4 weeks.
mmHg
change from baseline intraocular pressure at 6 weeks Ultrasound bimicroscopy (UBM)
Time frame: 6 weeks post-operatively.
mm Hg
change from baseline intraocular pressure at 3 months
Time frame: 3 months postoperatively
mmHg
change from baseline intraocular pressure at 6 months
Time frame: 6 months postoperatively
mmHg

2 secondary outcomes

change from baseline best corrected visual acuity (BCVA) at 6 months
Time frame: at the end of 6 months
extent of filtering bleb area by ultrasound of bio-microscopy (UBM)
Time frame: 6 weeks postoperatively

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
Background: PubMed 10690829El Sayyad F, Belmekki M, Helal M, Khalil M, El-Hamzawey H, Hisham M. Simultaneous subconjunctival and subscleral mitomycin-C application in trabeculectomy. Ophthalmology. 2000 Feb;107(2):298-301; discussion 302. doi: 10.1016/s0161-6420(99)00097-4.
Background: PubMed 9327347Nuijts RM, Vernimmen RC, Webers CA. Mitomycin C primary trabeculectomy in primary glaucoma of white patients. J Glaucoma. 1997 Oct;6(5):293-7.
Individual participant dataSharing planned: Undecided. study protocol Statistical analysis plan within 6 months after completing the study

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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.

Riham S Allam, MD, FRCS GL principal investigator

Associate Professor of Ophthalmology , Cairo university

Karim A Raafat, MD principal investigator

Professor of Ophthalmology , Cairo university

Rehab M Mohamed, MD principal investigator

lecturer of Ophthalmology , Cairo university

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SST in group (A) and trabeculectomy with ESST in group (B) in people with Primary Open-angle Glaucoma, run by Rehab mahmoud abdelhamid mohamed 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 5 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: finished, as of the sponsor's last update on 19 Jul 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change from baseline intraocular pressure at first day postoperative (time frame: day one postoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03480711, which also lists 2 linked publications.

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 19 Jul 2022.