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

Primary Purpose

Primary Open-angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SST in group (A)
trabeculectomy with ESST in group (B)
Sponsored by
Rehab mahmoud abdelhamid mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring subscleral trabeculectomy, extended subscleral tunnel, mitomycinC

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of medicind

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group (A)

group (B)

Arm Description

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

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)

Outcomes

Primary Outcome Measures

change from baseline intraocular pressure at first day postoperative
mmHg
change from baseline intraocular pressure at 4 weeks
mmHg
change from baseline intraocular pressure at 6 weeks Ultrasound bimicroscopy (UBM)
mm Hg
change from baseline intraocular pressure at 3 months
mmHg
change from baseline intraocular pressure at 6 months
mmHg

Secondary Outcome Measures

change from baseline best corrected visual acuity (BCVA) at 6 months
logarithm of minimal angle of resolution (log MAR)
extent of filtering bleb area by ultrasound of bio-microscopy (UBM)
width, depth and height of filtering bleb area in millimeter

Full Information

First Posted
March 15, 2018
Last Updated
July 18, 2022
Sponsor
Rehab mahmoud abdelhamid mohamed
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03480711
Brief Title
Modified Trabeculectomy With an ESST Versus Conventional SST for Management of Primary Open Angle Glaucoma
Acronym
POAG
Official Title
Modified Trabeculectomy With an Extended Subscleral Tunnel Versus Conventional Trabeculectomy for Management of Primary Open Angle Glaucoma (POAG)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
March 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rehab mahmoud abdelhamid mohamed
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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%).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma
Keywords
subscleral trabeculectomy, extended subscleral tunnel, mitomycinC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized non-controlled comparative prospective interventional study
Masking
ParticipantOutcomes Assessor
Masking Description
participants are going to be randomly assigned into two groups outcomes assessor will asses visual acuity and BCVA IOP using Goldmann applanation tonometry slit-lamp and fundus examination of cup-disc ratio, Ultrasound Biomicroscopy (UBM) to assese ostium patency and extent of bleb area will be done once after 6 weeks post-operatively. Colored photography of the filtering blebs will be performed for grading. Bleb grading will be classified according moorfields grading scale Perimetry will be performed at the end of follow up.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (A)
Arm Type
Experimental
Arm Description
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
Arm Title
group (B)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
SST in group (A)
Other Intervention Name(s)
subscleral trabeculectomy, conventional trabeculectomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
trabeculectomy with ESST in group (B)
Other Intervention Name(s)
modified trabeculectomy, extended subscleral tunnel
Intervention Description
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)
Primary Outcome Measure Information:
Title
change from baseline intraocular pressure at first day postoperative
Description
mmHg
Time Frame
day one postoperatively
Title
change from baseline intraocular pressure at 4 weeks
Description
mmHg
Time Frame
, 4 weeks.
Title
change from baseline intraocular pressure at 6 weeks Ultrasound bimicroscopy (UBM)
Description
mm Hg
Time Frame
6 weeks post-operatively.
Title
change from baseline intraocular pressure at 3 months
Description
mmHg
Time Frame
3 months postoperatively
Title
change from baseline intraocular pressure at 6 months
Description
mmHg
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
change from baseline best corrected visual acuity (BCVA) at 6 months
Description
logarithm of minimal angle of resolution (log MAR)
Time Frame
at the end of 6 months
Title
extent of filtering bleb area by ultrasound of bio-microscopy (UBM)
Description
width, depth and height of filtering bleb area in millimeter
Time Frame
6 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riham S Allam, MD, FRCS GL
Organizational Affiliation
Associate Professor of Ophthalmology , Cairo university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karim A Raafat, MD
Organizational Affiliation
Professor of Ophthalmology , Cairo university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rehab M Mohamed, MD
Organizational Affiliation
lecturer of Ophthalmology , Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicind
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
study protocol Statistical analysis plan within 6 months after completing the study
Citations:
PubMed Identifier
10690829
Citation
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.
Results Reference
background
PubMed Identifier
9327347
Citation
Nuijts RM, Vernimmen RC, Webers CA. Mitomycin C primary trabeculectomy in primary glaucoma of white patients. J Glaucoma. 1997 Oct;6(5):293-7.
Results Reference
background

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

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