Punch Trabeculectomy Versus Classic Trabeculectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Values of Releasable Sutures in Punch Trabeculectomy Prospective Randomized Study

Conditions
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Glaucoma, Open-Angle

Intervention / Treatment
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* Procedure: releasable sutures in punch trabeculectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tight flap technique group (forty patients-group A)<br>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<br>* punch trabeculectomy,scleral flap suturing<br>* Other names: loose flap technique versus tight flap technique in punch trabeculectomy;|
| Experimental: loose flap technique (securing sutures) group (forty patients-group B).<br>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<br>* punch trabeculectomy,scleral flap suturing<br>* Other names: loose flap technique versus tight flap technique in punch trabeculectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleb morphology after surgery | 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). | one-year follow up |