Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
NCT ID: NCT00444080
Last Updated: 2020-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2006-10-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Arm
Subjects undergoing trabeculectomy with the use of Mitomycin C
Trabeculectomy
Standard trabeculectomy procedure
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of a limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. Creation of fistula 1mm x 2mm in size
5. Iridectomy
6. Suturing the scleral flap
7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged.
Treatment Arm
Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
Ex-PRESS mini shunt
Ex-PRESS implantation procedure:
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. 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
5. Prior to implantation, a thorough mobility check should be performed
6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
7. Withdrawal of introducer
8. Tucking plate under the scleral flap, and verification of its position
9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad - patient is discharged.
Interventions
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Trabeculectomy
Standard trabeculectomy procedure
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of a limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. Creation of fistula 1mm x 2mm in size
5. Iridectomy
6. Suturing the scleral flap
7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged.
Ex-PRESS mini shunt
Ex-PRESS implantation procedure:
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. 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
5. Prior to implantation, a thorough mobility check should be performed
6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
7. Withdrawal of introducer
8. Tucking plate under the scleral flap, and verification of its position
9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad - patient is discharged.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
100 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Peter Netland, MD
Vernah Scott Moyston Professor, Chair, Department of Ophthalmology
Principal Investigators
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Peter A. Netland, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of California
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
Washington University
St Louis, Missouri, 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
University of Tennessee
Memphis, Tennessee, United States
Osler Eyecare
Mississauga, Ontario, Canada
Countries
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References
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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.
Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Study results indexed on Pub Med
Other Identifiers
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14967
Identifier Type: -
Identifier Source: org_study_id
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