Punch Trabeculectomy Versus Classic Trabeculectomy

NCT ID: NCT04651231

Last Updated: 2020-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-20
• Study Completion Date: 2014-10-16

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.

Conditions

Glaucoma, Open-Angle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

releasable sutures in punch trabeculectomy

Intervention Type: PROCEDURE

punch trabeculectomy,scleral flap suturing

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.

Group Type: EXPERIMENTAL

releasable sutures in punch trabeculectomy

Intervention Type: PROCEDURE

punch trabeculectomy,scleral flap suturing

Interventions

releasable sutures in punch trabeculectomy

punch trabeculectomy,scleral flap suturing

Intervention Type: PROCEDURE

Other Intervention Names

loose flap technique versus tight flap technique in punch trabeculectomy

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

khaled hamdi elbaklish

assistant professor- ophthalmic department- faculty of medicine-Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FWA000017585-FMASU R23/2017

Identifier Type: -

Identifier Source: org_study_id