Punch Trabeculectomy Versus Classic Trabeculectomy

• ClinicalTrials.gov Identifier: NCT04651231
• Recruitment Status: Completed
• First Posted: December 3, 2020
• Last Update Posted: December 3, 2020
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): khaled hamdi elbaklish, Ain Shams University

Study Description

Brief Summary:

Bleb failure is reduced with Punch trabeculectomy procedure. Wide sclerostomy during surgery is wanted but controllable. This can be done with single securing suture, releasable sutures and topical intraoperative mitomycin-c. Average IOP without fluctuation (risk factor) can protect the optic nerve.

Condition or disease	Intervention/treatment	Phase
Glaucoma, Open-Angle	Procedure: releasable sutures in punch trabeculectomy	Not Applicable

Detailed Description:

This is a prospective randomized study. Patients had uncontrolled glaucoma on maximum tolerated medical therapy including acetazolamide tablets were enrolled in this clinical trial and were randomized to tight flap technique group (group A) and loose flap technique group(group B). Randomization assigned 40 patients to group A and 40 patients to do group B. A total of 80 patients were enrolled in the Study between 2012 and 2014.

During trabeculectomy, Trabecular meshwork and scleral lamellae were excised made an opening with the kelly scleral punch 1.0 mm 3-5 bites. At 12 o'clock 10/0 nylon monofilament stitch was used to close the apex of triangular scleral flap tightly and two releasable stitches were used at the sides of triangular scleral flap in group A. Fig-1 At 12 o'clock 10/0 nylon monofilament stitch was used to secure the edges of the flap at the apex of and two-four releasable stitches were used at the sides of triangular scleral flap in group B. The intraocular pressure and bleb morphology were followed for one year after surgery.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Eighty Patients inclusive, randomly distributed for tight flap technique group (forty patients-group A) and for loose flap technique (securing sutures) group (forty patients-group B).
• Masking: Single (Participant)
• Masking Description: The participants were masked during study time through permuted variable block randomization scheme.
• Primary Purpose: Treatment
• Official Title: Values of Releasable Sutures in Punch Trabeculectomy Prospective Randomized Study
• Actual Study Start Date: January 20, 2012
• Actual Primary Completion Date: June 28, 2014
• Actual Study Completion Date: October 16, 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: tight flap technique group (forty patients-group A); in this arm forty patients did tight flap technique for punch trabeculectomy. At 12 o'clock 10/0 nylon monofilament stitch was used to close the apex of triangular scleral flap tightly and two releasable stitches were used at the sides of triangular scleral flap.	Procedure: releasable sutures in punch trabeculectomy; punch trabeculectomy,scleral flap suturing; Other Name: loose flap technique versus tight flap technique in punch trabeculectomy
Experimental: loose flap technique (securing sutures) group (forty patients-group B).; in this arm forty patients did loose flap technique for punch trabeculectomy. At 12 o'clock 10/0 nylon monofilament stitch was used to secure the edges of the flap at the apex of and two-four releasable stitches were used at the sides of triangular scleral flap in group B.	Procedure: releasable sutures in punch trabeculectomy; punch trabeculectomy,scleral flap suturing; Other Name: loose flap technique versus tight flap technique in punch trabeculectomy

Outcome Measures

Primary Outcome Measures :

1. postoperative intraocular pressure (IOP) [ Time Frame: one-year follow up ]
   measuring IOP at first day ,first month, three months, six months, nine months,and one year after surgery frequent interval in both groups with applanation method( Goldmann applanation tonometer

Secondary Outcome Measures :

1. bleb morphology after surgery [ Time Frame: one-year follow up ]
   examination of bleb formed after surgery with Silt Lamp.we comment on the bleb features on each patient in study groups as grade-1 (high elevated bleb), grade-2 (low elevated bleb), grade-3-(encysted bleb), grade-4 (flat bleb).

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Clinical diagnosis of primary open-angle glaucoma
• Clinical diagnosis of pigmentary glaucoma
• Clinical diagnosis of Pseudophakic glaucoma

Exclusion Criteria:

• high risk factors for failed trabeculectomy must be present e.g. previous failed trabeculectomy surgery and active intraocular infection/ inflammation.
• Clinical diagnosis of aphakic glaucoma was excluded.
• Clinical diagnosis of glaucoma with previous ocular incisional surgery (except for clear cornea cataract surgery) were excluded.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: khaled hamdi elbaklish, assistant professor- ophthalmic department- faculty of medicine-Ain Shams University, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04651231
• Other Study ID Numbers: FWA000017585-FMASU R23/2017
• First Posted: December 3, 2020
• Last Update Posted: December 3, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Given the data in determining evidence-based medicine and evidence-based public health policies, sharing this type of data is seen as particularly important.

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

Additional relevant MeSH terms:

Glaucoma, Open-Angle; Glaucoma; Ocular Hypertension; Eye Diseases