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Completed

NCT Number: NCT04651231

Punch Trabeculectomy Versus Classic Trabeculectomy

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

releasable sutures in punch trabeculectomy

Procedure

punch trabeculectomy,scleral flap suturing

Other names: loose flap technique versus tight flap technique in punch trabeculectomy

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Values of Releasable Sutures in Punch Trabeculectomy Prospective Randomized Study

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 3, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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