Open Angle Glaucoma Clinical Trial
Official title:
Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients
In the management of open angle glaucoma, frequently more then one procedure is necessary to control the intra ocular pressure. There is still no consensus whether this second intervention should be a second trabeculectomy or a shunt device. In the present study we compare a second trabeculectomy versus Ahmed silicone shunt device in open angle glaucoma patients with previous trabeculectomy without proper IOP control.
In the management of open angle glaucoma, frequently more then one procedure is necessary to
control the intra ocular pressure. There is still no consensus whether this second
intervention should be a second trabeculectomy or a shunt device. In the present study we
compare a second trabeculectomy versus Ahmed silicone shunt device in open angle glaucoma
patients with previous trabeculectomy without proper IOP control.
40 Patients with clinically uncontrolled open angle glaucoma with previous trabeculectomy
surgery were selected from the glaucoma sector of Federal university of Sao Paulo. Patients
were randomized to one of two groups:
1. Silicone Ahmed Implant
2. Second trabeculectomy
Surgery description:
Ahmed silicone tube implant: A fornix-based conjunctival flap was created between two
adjacent recti muscles. Before placement of the tube implant body to the sclera, tube was
irrigated with saline solution to open the valve mechanism. The implant's polypropylene body
was sutured to sclera with 6.0 silk suture. The tube then trimmed and the anterior chamber
was entered from 1mm posterior to corneoscleral limbus with 23-gauge needle. A human donor
scleral flap was placed over the tube and sutured to the sclera with 10.0 nylon suture. The
conjunctiva was sutured to the limbus.
Second Trabeculectomy: A fornix-based conjunctival flap was created in the opposite superior
quadrant of the previous trabeculectomy. Mitomycin-C was used under the conjunctival flap
for up to 4 minutes (0,3mg/mL) and rinsed with 30mL saline solution. Scleral flap with
crescent bevel and sclerectomy with a punch. Iridectomy and flap suture with nylon 10-0.
Conjunctival suture with nylon 10-0.
Follow up after surgery was in the 1st, 4th, 7th, 15th, 30th days and after that monthly or
whenever needed for clinical reasons.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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