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

Lahey Health

Status

Completed

Conditions

Glaucoma

Cataracts

Treatments

Procedure: 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT00695747

98-067

Details and patient eligibility

About

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

Full 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.

Enrollment

95 patients

Sex

All

Volunteers

No Healthy Volunteers

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