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NCT Number: NCT03480711

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

* 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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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicind

Cairo, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SST in group (A)

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

Other names: subscleral trabeculectomy, conventional trabeculectomy

trabeculectomy with ESST in group (B)

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)

Other names: modified trabeculectomy, extended subscleral tunnel

Primary outcomes

  1. change from baseline intraocular pressure at first day postoperative

    Time frame: day one postoperatively

    mmHg

  2. change from baseline intraocular pressure at 4 weeks

    Time frame: , 4 weeks.

    mmHg

  3. change from baseline intraocular pressure at 6 weeks Ultrasound bimicroscopy (UBM)

    Time frame: 6 weeks post-operatively.

    mm Hg

  4. change from baseline intraocular pressure at 3 months

    Time frame: 3 months postoperatively

    mmHg

  5. change from baseline intraocular pressure at 6 months

    Time frame: 6 months postoperatively

    mmHg

Secondary outcomes

  1. change from baseline best corrected visual acuity (BCVA) at 6 months

    Time frame: at the end of 6 months

    logarithm of minimal angle of resolution (log MAR)

  2. extent of filtering bleb area by ultrasound of bio-microscopy (UBM)

    Time frame: 6 weeks postoperatively

    width, depth and height of filtering bleb area in millimeter

Sponsors and collaborators

Lead sponsor

Rehab mahmoud abdelhamid mohamed

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Acronym: POAG

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Jul 19, 2022

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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