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

Not Applicable

Completed

• Conditions: Glaucoma; Cataracts
• Interventions: Procedure: 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy

• Registration Number: NCT00695747
• Lead Sponsor: Lahey Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 1998-01
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-12
• Status Verified: 2009-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2009-01-21
• Last Update Posted: 2009-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	2 Site procedure- Phacoemulsification/IOL and Trabeculectomy	2 Site Combined Procedure

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lahey Clinic, Inc.; 🇺🇸 Burlington, Massachusetts, United States