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

Glaucoma Clinical Trial

Official title:

A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444080
• Other study ID #: 14967
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: January 2012

Study information

• Verified date: September 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Procedure:
• Trabeculectomy
Standard trabeculectomy procedure Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of a limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Creation of fistula 1mm x 2mm in size Iridectomy Suturing the scleral flap Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged.

Device:
• Ex-PRESS mini shunt
Ex-PRESS implantation procedure: Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus Prior to implantation, a thorough mobility check should be performed Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision Withdrawal of introducer Tucking plate under the scleral flap, and verification of its position Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged.

Locations

Country	Name	City	State
Canada	Osler Eyecare	Mississauga	Ontario
United States	University of Florida	Gainesville	Florida
United States	University of Tennessee	Memphis	Tennessee
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	Washington University	Saint Louis	Missouri
United States	University of California	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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.e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Intraocular Pressure	Mean postoperative intraocular pressure	assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
Primary	Medications		assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported
Secondary	Safety - Incidence of Adverse Events	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.	24 months
Secondary	Efficacy - The Number of Participants With Qualified and Complete Success	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	24 months

External Links

•   Study results indexed on Pub Med