Punch Trabeculectomy Versus Classic Trabeculectomy

Ain Shams University

Status: Completed

Conditions: Glaucoma, Open-Angle

Treatments: Procedure: releasable sutures in punch trabeculectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04651231

FWA000017585-FMASU R23/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

tight flap technique group (forty patients-group A)

Active Comparator group

Description:

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.

Treatment:

Procedure: releasable sutures in punch trabeculectomy

loose flap technique (securing sutures) group (forty patients-group B).

Experimental group

Description:

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.

Treatment:

Procedure: releasable sutures in punch trabeculectomy