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

Browse trials for

• Glaucoma 1,814
• Glaucoma, Open-Angle 928

Keywords

• subscleral trabeculectomy
• extended subscleral tunnel
• mitomycinC

Study arms

• Experimental
  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

  Procedure: SST in group (A)

• Experimental
  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)

  Procedure: trabeculectomy with ESST in group (B)

Interventions

• ProcedureSST 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

  Also known as: subscleral trabeculectomy, conventional trabeculectomy

• Proceduretrabeculectomy 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)

  Also known as: modified trabeculectomy, extended subscleral tunnel

Primary outcomes

1. change from baseline intraocular pressure at first day postoperative

   mmHg

   Time frame: day one postoperatively

2. change from baseline intraocular pressure at 4 weeks

   mmHg

   Time frame: , 4 weeks.

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

   mm Hg

   Time frame: 6 weeks post-operatively.

4. change from baseline intraocular pressure at 3 months

   mmHg

   Time frame: 3 months postoperatively

5. change from baseline intraocular pressure at 6 months

   mmHg

   Time frame: 6 months postoperatively

Secondary outcomes

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

   logarithm of minimal angle of resolution (log MAR)

   Time frame: at the end of 6 months

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

   width, depth and height of filtering bleb area in millimeter

   Time frame: 6 weeks postoperatively

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 ↗

Individual participant data

Plan to share: Undecided — study protocol Statistical analysis plan within 6 months after completing the study