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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Ex-PRESS mini shunt	Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
Control Arm	Trabeculectomy	Subjects undergoing trabeculectomy with the use of Mitomycin C

Primary Outcome Measures

Name	Time	Method
Postoperative Intraocular Pressure	assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported	Mean postoperative intraocular pressure
Medications	assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported

Secondary Outcome Measures

Name	Time	Method
Efficacy - The Number of Participants With Qualified and Complete Success	24 months	The secondary effectiveness measure will be qualified and complete success rate defined as IOP≤18mmHg with or without medications in the test group as compared to qualified and complete success rate in the concurrent control group at 24 month
Safety - Incidence of Adverse Events	24 months	Comparison of the incidence of all adverse events that occur during the intra-operative and postoperative periods between the two study arms. More than 1 complication may have occurred in the same subject.

Locations (8): University of Tennessee
🇺🇸
Memphis, Tennessee, United States
Washington University
🇺🇸
Saint Louis, Missouri, United States
University of California
🇺🇸
San Francisco, California, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
Dean A. McGee Eye Institute
🇺🇸
Oklahoma City, Oklahoma, United States
Wills EYE Institute
🇺🇸
Philadelphia, Pennsylvania, United States
Allegheny Ophthalmic & Orbital Associates, P.C.
🇺🇸
Pittsburgh, Pennsylvania, United States
Osler Eyecare
🇨🇦
Mississauga, Ontario, Canada