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| Name | Class |
|---|---|
| Cairo University | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (A) | Experimental | 20 eyes of 20 patients of uncontrolled POAG administrated intervention will be subscleral trabeculectomy (SST) single surgeon, using retrobulbar anaesthesia with 2% lidocaine, will be performed in all surgeries. Following insertion of a lid speculum, a 10/0 silk bridle suture is inserted at superior limbus if required. In group (A) a conjunctival incision is made at the limbus to create a fornix-based conjunctival flap. A half thickness scleral flap (4 × 4 mm) are created and dissected into the clear cornea. A cellulose microsponge soaked in 0.3 mg/ml MMC solution (Mitomycin-C) is applied to the under surface of the scleral flap over a wide posterior area for 2 ml |
|
| group (B) | Experimental | 20 eyes of 20 patients of uncontrolled POAG d Administrated intervention will be ESST another longitudinal scleral groove will be created in the center of the deep scleral bed area measured about 1.5 × 6 mm.In both groups, standard trabeculectomy of equal size (two bites aside) is created by a Kelly punch ( 1 mm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SST in group (A) | Procedure | group (A) single surgeon, using retrobulbar anaesthesia with 2% lidocaine, will be performed in all surgeries. Following insertion of a lid speculum, a 10/0 silk bridle suture is inserted at superior limbus if required. In group (A) a conjunctival incision is made at the limbus to create a fornix-based conjunctival flap. A half thickness scleral flap (4 × 4 mm) are created and dissected into the clear cornea. A cellulose microsponge soaked in 0.3 mg/ml MMC solution (Mitomycin-C) is applied to the under surface of the scleral flap over a wide posterior area for 2 ml |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline intraocular pressure at first day postoperative | mmHg | day one postoperatively |
| change from baseline intraocular pressure at 4 weeks | mmHg | , 4 weeks. |
| change from baseline intraocular pressure at 6 weeks Ultrasound bimicroscopy (UBM) | mm Hg | 6 weeks post-operatively. |
| change from baseline intraocular pressure at 3 months | mmHg | 3 months postoperatively |
| change from baseline intraocular pressure at 6 months | mmHg | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline best corrected visual acuity (BCVA) at 6 months | logarithm of minimal angle of resolution (log MAR) | at the end of 6 months |
| extent of filtering bleb area by ultrasound of bio-microscopy (UBM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Riham S Allam, MD, FRCS GL | Associate Professor of Ophthalmology , Cairo university | Principal Investigator |
| Karim A Raafat, MD | Professor of Ophthalmology , Cairo university | Principal Investigator |
| Rehab M Mohamed, MD | lecturer of Ophthalmology , Cairo university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicind | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10690829 | Background | El Sayyad F, Belmekki M, Helal M, Khalil M, El-Hamzawey H, Hisham M. Simultaneous subconjunctival and subscleral mitomycin-C application in trabeculectomy. Ophthalmology. 2000 Feb;107(2):298-301; discussion 302. doi: 10.1016/s0161-6420(99)00097-4. | |
| 9327347 | Background | Nuijts RM, Vernimmen RC, Webers CA. Mitomycin C primary trabeculectomy in primary glaucoma of white patients. J Glaucoma. 1997 Oct;6(5):293-7. |
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study protocol Statistical analysis plan within 6 months after completing the study
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
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Randomized non-controlled comparative prospective interventional study
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participants are going to be randomly assigned into two groups outcomes assessor will asses
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|
| trabeculectomy with ESST in group (B) | Procedure | group (B), another longitudinal scleral groove will be created in the center of the deep scleral bed area measured about 1.5 × 6 mm.In both groups, standard trabeculectomy of equal size (two bites aside) is created by a Kelly punch ( 1 mm) |
|
|
width, depth and height of filtering bleb area in millimeter
| 6 weeks postoperatively |
| D013514 | Surgical Procedures, Operative |