NCT03480711

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Rehab mahmoud abdelhamid mohamed · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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
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)

Timeline

• Start date: 2018-07-10
• Primary completion: 2019-02-28
• Completion: 2019-03-02
• First posted: 2018-03-29
• Last updated: 2022-07-19

Locations

1 site across 1 country: Egypt