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

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ClinicalTrials.gov Identifier: NCT03480711
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Rehab mahmoud abdelhamid mohamed, Cairo University

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%).

Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Procedure: SST in group (A) Procedure: trabeculectomy with ESST in group (B) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized non-controlled comparative prospective interventional study
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.
Primary Purpose: Treatment
Official Title: Modified Trabeculectomy With an Extended Subscleral Tunnel Versus Conventional Trabeculectomy for Management of Primary Open Angle Glaucoma (POAG)
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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)
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

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)
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480711


Contacts
Contact: Rehab M Mohamed, MD +201063007333 rehabgazala@gmail.com
Contact: Riham S Allam, MD,FRCS GL +201001873843 ryham_allam@yahoo.com

Locations
Egypt
Faculty of medicind Recruiting
Cairo, Egypt
Contact: Rehab M Mohamed, MSc    01063007333    Rehabgazala@gmail.com   
Sponsors and Collaborators
Rehab mahmoud abdelhamid mohamed
Cairo University
Investigators
Principal Investigator: 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 Assistant lecturer of Ophthalmology , Cairo university

Publications:
Responsible Party: Rehab mahmoud abdelhamid mohamed, assistant lecturer of ophthalmology,ophthalmology department, medical school, Cairo University
ClinicalTrials.gov Identifier: NCT03480711     History of Changes
Other Study ID Numbers: N-38-2018
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: study protocol Statistical analysis plan within 6 months after completing the study

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rehab mahmoud abdelhamid mohamed, Cairo University:
subscleral trabeculectomy
extended subscleral tunnel
mitomycinC

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases