Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
1 other identifier
interventional
120
2 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2006
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 5, 2007
CompletedFirst Posted
Study publicly available on registry
March 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
October 14, 2020
CompletedOctober 14, 2020
September 1, 2020
5.3 years
March 5, 2007
August 27, 2020
September 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Postoperative Intraocular Pressure
Mean postoperative intraocular pressure
assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
Medications
assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported
Secondary Outcomes (2)
Safety - Incidence of Adverse Events
24 months
Efficacy - The Number of Participants With Qualified and Complete Success
24 months
Study Arms (2)
Control Arm
ACTIVE COMPARATORSubjects undergoing trabeculectomy with the use of Mitomycin C
Treatment Arm
EXPERIMENTALSubjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
Interventions
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 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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of California
San Francisco, California, 94143-0730, United States
University of Florida
Gainesville, Florida, 32610, United States
Washington University
St Louis, Missouri, 63110, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Wills EYE Institute
Philadelphia, Pennsylvania, 19066, United States
Allegheny Ophthalmic & Orbital Associates, P.C.
Pittsburgh, Pennsylvania, 15212, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
Osler Eyecare
Mississauga, Ontario, L5B 1N5, Canada
Related Publications (2)
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.
PMID: 24210765RESULTPark 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.
PMID: 36912740DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter A. Netland, MD, PhD
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Peter A. Netland, MD, PhD
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vernah Scott Moyston Professor, Chair, Department of Ophthalmology
Study Record Dates
First Submitted
March 5, 2007
First Posted
March 7, 2007
Study Start
October 1, 2006
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
October 14, 2020
Results First Posted
October 14, 2020
Record last verified: 2020-09