Punch Trabeculectomy Versus Classic Trabeculectomy

Not Applicable

Completed

• Conditions: Glaucoma, Open-Angle
• Interventions: Procedure: releasable sutures in punch trabeculectomy

• Registration Number: NCT04651231
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study Start: 2012-01-20
• Primary Completion: 2014-06-28
• Study Completion: 2014-10-16
• Status Verified: 2020-11
• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-26
• Last Update Submitted: 2020-11-26
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tight flap technique group (forty patients-group A)	releasable sutures in punch trabeculectomy	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.
loose flap technique (securing sutures) group (forty patients-group B).	releasable sutures in punch trabeculectomy	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.

Primary Outcome Measures

Name	Time	Method
postoperative intraocular pressure (IOP)	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

Name	Time	Method
bleb morphology after surgery	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).