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

Sponsors and Collaborators:	University of Tennessee Optonol
Information provided by:	University of Tennessee
ClinicalTrials.gov Identifier:	NCT00444080

Purpose

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

Condition	Intervention	Phase
Glaucoma	Procedure: Trabeculectomy Device: Ex-PRESS mini shunt	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

Further study details as provided by University of Tennessee:

Primary Outcome Measures:

Safety - Post operative safety profile defined as vitreous loss and hypotony (IOP≤5mmHg) and related complications (choroidal effusion, hyphema, shallow/flat AC, leaking bleb). [ Time Frame: 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m ] [ Designated as safety issue: No ]
Efficacy - The primary effectiveness measure will be qualified and complete success rate defined as IOP≤18mmHg with or without medications in the test group as compared to complete and qualified success rate in the concurrent control group at 12 months. [ Time Frame: 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety - Comparison of the incidence of all adverse events that occur during the intra-operative and postoperative periods between the two study arms. [ Time Frame: 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m ] [ Designated as safety issue: No ]
Efficacy - 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 [ Time Frame: 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control Arm: Active Comparator Subjects undergoing trabeculectomy with the use of Mitomycin C	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.
Treatment Arm: Experimental Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C	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.

Arms

Assigned Interventions

Control Arm: Active Comparator

Subjects undergoing trabeculectomy with the use of Mitomycin C

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.

Treatment Arm: Experimental

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

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.

Detailed Description:

Note that Optonol is the actual sponsor of the trial. The University of Tennessee placed the information on clinicaltrials.gov.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 intra-operative anti-metabolites
IOP > 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit.
Subject underwent clear corneal phacoemulsification at least 3 months prior to initiation 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 had cataract extraction within the last three months
Subject is a candidate for cataract extraction combined with glaucoma surgery
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 presents vitreous in the anterior chamber for which vitrectomy is anticipated
IOP of ≤18mmHg
Subject participates in any other concurrent ocular investigation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444080

Contacts

Contact: Haiming Du, MD, PHD

hdu@utmem.edu

Locations

United States, California
University of California	Not yet recruiting
San Francisco, California, United States, 94143-0730
Principal Investigator: Robert L Stamper, MD, PHD
United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Mark B Sherwood, MD, PHD
United States, Oklahoma
Dean A. McGee Eye Institute	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Principal Investigator: Steven R Sarkisian, MD, PHD
United States, Pennsylvania
Wills EYE Institute	Recruiting
Philadelphia, Pennsylvania, United States, 19066
Principal Investigator: Marlene R Moster, MD, PHD
United States, Tennessee
University of Tennessee	Recruiting
Memphis, Tennessee, United States, 38163
Principal Investigator: Peter A Netland, MD, PHD

Sponsors and Collaborators

University of Tennessee

Optonol

Investigators

Principal Investigator:

Peter A Netland, MD, PHD

University of Tennessee

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Maris PJ Jr, Ishida K, Netland PA. Comparison of trabeculectomy with Ex-PRESS miniature glaucoma device implanted under scleral flap. J Glaucoma. 2007 Jan;16(1):14-9.

Responsible Party:	University of Tennessee ( Peter Netland, MD, Professor )
Study ID Numbers:	XVT-01
Study First Received:	March 5, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00444080 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Tennessee:

Ex-PRESS
TRABECULECTOMY

Study placed in the following topic categories:

Anti-Bacterial Agents
Glaucoma
Eye Diseases

Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Ocular Hypertension

ClinicalTrials.gov processed this record on May 06, 2009