Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy

Conditions
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Glaucoma, Cataracts

Intervention / Treatment
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* Procedure: 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the current criteria for combined procedure surgery: A visually significant cataract(ie: an opacification of the crystalline lens resulting in a reduction of visual performance affecting daily living Open angle or mixed mechanism glaucoma inadequately controlled on current therapy, or requiring two or more medications for control, or with advanced visual field and optic nerve damage. Exclusion Criteria: Subjects with normal tension glaucoma(defined as those subjects in whom no IOPs greater than 21 mm Hg[preceding or during therapy]have been recorded) Subjects with uveitis Subjects with neovascular glaucoma Severe conjunctival inflammation or scarring Subjects who have had previous incisional ocular surgery in the same eye No subjects will have second eye operated on within 8 weeks of the first eye
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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Standard 1 site Procedure using a fornix based incision, performed superiorly | |
| Experimental: 2<br>2 Site Combined Procedure | Procedure: 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy<br>* 2 Site Combined Procedure: in which a temporal clear cornea approach would be used for the cataract/IOL part of the procedure, and immediately thereafter the superior limbus would be employed for a limbus-based trabeculectomy<br>* Other names: Trabeculectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Op outcomes of IOP less than or equal to 16mm Hg without additional ocular hypotensive medications |  | Assessments made at 3 months post op, 3 month intervals for at least 2 years post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Cataracts, Phacoemulsification(IOL), Trabeculectomy