Glaucoma Clinical Trial
Official title:
Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy
The purpose of this study is to compare the safety & effectiveness of the two types of cataract and glaucoma surgeries. Results from this study may improve the surgical and post surgical management and long term management of patients with these conditions in the future
The purpose of this study is to determine whether a Two-Site Technique for the Combined
Procedure for subjects with coexisting visually significant glaucoma & cataracts will result
in an improvement in IOP control in both the immediate and longer term postoperative period
as compared with the currently Standard One Site surgical technique for both glaucoma and
cataracts.
Research and data indicate that the success rate of the glaucoma part of this operation may
be improved if the incision for the cataract part of the operation is separated from the
drainage hole created for the glaucoma part, the constant drainage through this hole is what
lowers the intraocular pressure after surgery. Using the Two-Site Combined procedure the
glaucoma incision(drainage hole) will still be created superiorly, under the upper lid. The
cataract incision will be moved to the temporal side of the eye ball, away from the drainage
hole for the glaucoma.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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