Values of Releasable Sutures in Punch Trabeculectomy Prospective Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 80
- Primary Endpoint
- postoperative intraocular pressure (IOP)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The participants were masked during study time through permuted variable block randomization scheme.
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- bleb morphology after surgery(one-year follow up)
Investigators
khaled hamdi elbaklish
assistant professor- ophthalmic department- faculty of medicine-Ain Shams University
Ain Shams University