Glaucoma, Open-Angle
Conditions
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.
Interventions
PROCEDUREreleasable sutures in punch trabeculectomy
punch trabeculectomy,scleral flap suturing
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The participants were masked during study time through permuted variable block randomization scheme.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative intraocular pressure (IOP) | 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
| Measure | Time frame | Description |
|---|---|---|
| bleb morphology after surgery | 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). |
Outcome results
None listed