Clinical trial NCT00444080: Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
Official title: A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Ex-PRESS
TRABECULECTOMY
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2007-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Intraocular Pressure
timeFrame: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
measure: Medications
timeFrame: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported
Secondary outcomes:
measure: Safety - Incidence of Adverse Events
timeFrame: 24 months
measure: Efficacy - The Number of Participants With Qualified and Complete Success
timeFrame: 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Oklahoma City
country: United States
facility: Dean A. McGee Eye Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Wills EYE Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Ophthalmic & Orbital Associates, P.C.
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Mississauga
country: Canada
facility: Osler Eyecare
state: Ontario
Study officials:
affiliation: University of Virginia
name: Peter A. Netland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Netland PA, Sarkisian SR Jr, Moster MR, Ahmed II, Condon G, Salim S, Sherwood MB, Siegfried CJ. Randomized, prospective, comparative trial of EX-PRESS glaucoma filtration device versus trabeculectomy (XVT study). Am J Ophthalmol. 2014 Feb;157(2):433-440.e3. doi: 10.1016/j.ajo.2013.09.014. Epub 2013 Nov 7.