Faculty of medicind
Cairo, Egypt
NCT Number: NCT03480711
* 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%).
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Notify Me40 year–70 year
All sexes
Interventional
Not applicable
Cairo, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: subscleral trabeculectomy, conventional trabeculectomy
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)
Other names: modified trabeculectomy, extended subscleral tunnel
Time frame: day one postoperatively
mmHg
Time frame: , 4 weeks.
mmHg
Time frame: 6 weeks post-operatively.
mm Hg
Time frame: 3 months postoperatively
mmHg
Time frame: 6 months postoperatively
mmHg
Time frame: at the end of 6 months
logarithm of minimal angle of resolution (log MAR)
Time frame: 6 weeks postoperatively
width, depth and height of filtering bleb area in millimeter
Rehab mahmoud abdelhamid mohamed
Other
Modified Trabeculectomy With an Extended Subscleral Tunnel Versus Conventional Trabeculectomy for Management of Primary Open Angle Glaucoma (POAG)
Acronym: POAG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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