Punch Trabeculectomy Versus Classic Trabeculectomy

NCT04651231 | Completed DMC

• 1 other identifier: FWA000017585-FMASU R23/2017
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• bleb morphology after surgery

  one-year follow up

Study Arms (2)

tight flap technique group (forty patients-group A)

ACTIVE COMPARATOR

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.

Procedure: releasable sutures in punch trabeculectomy

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

EXPERIMENTAL

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.

Procedure: releasable sutures in punch trabeculectomy

Interventions

releasable sutures in punch trabeculectomy PROCEDURE

punch trabeculectomy,scleral flap suturing

Also known as: loose flap technique versus tight flap technique in punch trabeculectomy

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

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of primary open-angle glaucoma
• Clinical diagnosis of pigmentary glaucoma
• Clinical diagnosis of Pseudophakic glaucoma

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants were masked during study time through permuted variable block randomization scheme.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor- ophthalmic department- faculty of medicine-Ain Shams University

Model Details: Eighty Patients inclusive, randomly distributed for tight flap technique group (forty patients-group A) and for loose flap technique (securing sutures) group (forty patients-group B).

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 3, 2020
• Study Start: January 20, 2012
• Primary Completion: June 28, 2014
• Study Completion: October 16, 2014
• Last Updated: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share