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

NCT03480711 | Completed DMC

• 1 other identifier: N-38-2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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%).

Conditions

Primary Open-angle Glaucoma

Keywords

subscleral trabeculectomy; extended subscleral tunnel; mitomycinC

Outcome Measures

Primary Outcomes (5)

• change from baseline intraocular pressure at first day postoperative

  mmHg

  day one postoperatively

• change from baseline intraocular pressure at 4 weeks

  mmHg

  , 4 weeks.

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

  mm Hg

  6 weeks post-operatively.

• change from baseline intraocular pressure at 3 months

  mmHg

  3 months postoperatively

• change from baseline intraocular pressure at 6 months

  mmHg

  6 months postoperatively

Secondary Outcomes (2)

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

  at the end of 6 months

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

  6 weeks postoperatively

Study Arms (2)

Group (A)

EXPERIMENTAL

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)

group (B)

EXPERIMENTAL

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

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

Also known as: subscleral trabeculectomy, conventional trabeculectomy

Group (A)

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)

Also known as: modified trabeculectomy, extended subscleral tunnel

group (B)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rehab mahmoud abdelhamid mohamed: lead
• Cairo University: collaborator

Study Sites (1)

Faculty of medicind

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 10690829 BACKGROUND

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

  PMID: 9327347 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Population Groups; Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Riham S Allam, MD, FRCS GL

  Associate Professor of Ophthalmology , Cairo university

  PRINCIPAL INVESTIGATOR

• Karim A Raafat, MD

  Professor of Ophthalmology , Cairo university

  PRINCIPAL INVESTIGATOR

• Rehab M Mohamed, MD

  lecturer of Ophthalmology , Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants are going to be randomly assigned into two groups outcomes assessor will asses 1. visual acuity and BCVA 2. IOP using Goldmann applanation tonometry 3. slit-lamp and fundus examination of cup-disc ratio, 4. Ultrasound Biomicroscopy (UBM) to assese ostium patency and extent of bleb area will be done once after 6 weeks post-operatively. 5. Colored photography of the filtering blebs will be performed for grading. Bleb grading will be classified according moorfields grading scale 6. Perimetry will be performed at the end of follow up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer of ophthalmology,ophthalmology department, medical school

Model Details: Randomized non-controlled comparative prospective interventional study

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 29, 2018
• Study Start: July 10, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 2, 2019
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

EG (1)