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

NCT ID: NCT03480711

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-10
• Study Completion Date: 2019-03-02

Brief 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 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.

Conditions

Primary Open-angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 Type: EXPERIMENTAL

SST in group (A)

Intervention Type: PROCEDURE

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

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)

Group Type: EXPERIMENTAL

trabeculectomy with ESST in group (B)

Intervention Type: PROCEDURE

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)

Interventions

SST in group (A)

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

Intervention Type: PROCEDURE

trabeculectomy with ESST in group (B)

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)

Intervention Type: PROCEDURE

Other Intervention Names

subscleral trabeculectomy; conventional trabeculectomy; modified trabeculectomy; extended subscleral tunnel

Eligibility Criteria

Inclusion Criteria

• 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 .

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Rehab mahmoud abdelhamid mohamed

OTHER

Sponsor Role: lead

Responsible Party

Rehab mahmoud abdelhamid mohamed

assistant lecturer of ophthalmology,ophthalmology department, medical school

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Riham S Allam, MD, FRCS GL

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Ophthalmology , Cairo university

Karim A Raafat, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Ophthalmology , Cairo university

Rehab M Mohamed, MD

Role: PRINCIPAL_INVESTIGATOR

lecturer of Ophthalmology , Cairo university

Locations

Faculty of medicind

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 10690829 (View on PubMed)

Nuijts RM, Vernimmen RC, Webers CA. Mitomycin C primary trabeculectomy in primary glaucoma of white patients. J Glaucoma. 1997 Oct;6(5):293-7.

Reference Type: BACKGROUND

PMID: 9327347 (View on PubMed)

Other Identifiers

N-38-2018

Identifier Type: -

Identifier Source: org_study_id