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Punch Trabeculectomy Versus Classic Trabeculectomy

A

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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