Punch Trabeculectomy Versus Classic Trabeculectomy

Glaucoma, Open-Angle Clinical Trial

Official title:

Values of Releasable Sutures in Punch Trabeculectomy Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651231
• Other study ID #: FWA000017585-FMASU R23/2017
• Status: Completed
• Phase: N/A
• Start date: January 20, 2012
• Est. completion date: October 16, 2014

Study information

• Verified date: November 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 16, 2014
• Est. primary completion date: June 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma, Open-Angle

Intervention

Procedure:
• releasable sutures in punch trabeculectomy
punch trabeculectomy,scleral flap suturing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative intraocular pressure (IOP)	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	one-year follow up
Secondary	bleb morphology after surgery	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).	one-year follow up