Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

University of Virginia

Status: Completed

Conditions: Glaucoma

Treatments: Procedure: Trabeculectomy; Device: Ex-PRESS mini shunt

Study type: Interventional

Funder types: Other

Identifiers

NCT00444080

14967

Details and patient eligibility

About

A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to medical treatment and for which filtering surgery is indicated. Surgical success was defined as 5 mmHg ≤ intraocular pressure ≤ 18 mmHg, with or without medications, without further glaucoma surgery. Postoperative intraocular pressure, number of medications, complications and success rates were followed for 2 years.

Enrollment: 120 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subject over the age of 18
• Subject diagnosed with open angle glaucoma (POAG, PXFG or PDSG) or ocular hypertension
• Subject is a candidate for filtering surgery with intraoperative anti-metabolites
• IOP > 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit.
• Subject willing to attend all follow-up evaluations
• Subject willing to sign informed consent.

Exclusion criteria

• Subject diagnosed with: PACG, NTG, secondary glaucoma, neovascular glaucoma
• Subject has history of glaucoma surgery (filtering, glaucoma drainage device, cyclo destructive procedures)
• Subject has history of penetrating keratoplasty (PKP)
• Subject underwent large incision extra capsular cataract extraction
• Subject had cataract phacoemulsification within the last month
• Subject has a visually significant cataract that is planned for extraction at the time of filtering surgery or within 12 months thereafter
• Any ocular disease or history in the operated eye other than glaucoma and cataract, such as uveitis, ocular infection, severe dry eye, severe blepharitis , active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, aphakia, and ocular pathology that may interfere with accurate IOP measurements
• Subject has vitreous present in the anterior chamber for which vitrectomy is anticipated
• IOP of ≤18mmHg
• Subject participates in any other concurrent ocular investigation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

Subjects undergoing trabeculectomy with the use of Mitomycin C

Treatment:

Procedure: Trabeculectomy

Treatment Arm

Experimental group

Description:

Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C

Treatment:

Device: Ex-PRESS mini shunt