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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Trabeculectomy
Ex-PRESS mini shunt
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Ex-PRESS, TRABECULECTOMY

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California
  • University of Florida
  • Washington University
  • Dean A. McGee Eye Institute
  • Wills EYE Institute
  • Allegheny Ophthalmic & Orbital Associates, P.C.
  • University of Tennessee
  • Osler Eyecare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Arm

Treatment Arm

Arm Description

Subjects undergoing trabeculectomy with the use of Mitomycin C

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

Outcomes

Primary Outcome Measures

Postoperative Intraocular Pressure
Mean postoperative intraocular pressure
Medications

Secondary Outcome Measures

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.
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

Full Information

First Posted
March 5, 2007
Last Updated
September 21, 2020
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT00444080
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Ex-PRESS, TRABECULECTOMY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Subjects undergoing trabeculectomy with the use of Mitomycin C
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ex-PRESS mini shunt
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Intraocular Pressure
Description
Mean postoperative intraocular pressure
Time Frame
assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
Title
Medications
Time Frame
assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported
Secondary Outcome Measure Information:
Title
Safety - Incidence of Adverse Events
Description
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.
Time Frame
24 months
Title
Efficacy - The Number of Participants With Qualified and Complete Success
Description
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
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A. Netland, MD, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0730
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dean A. McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Wills EYE Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19066
Country
United States
Facility Name
Allegheny Ophthalmic & Orbital Associates, P.C.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Osler Eyecare
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1N5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24210765
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/24210765/
Description
Study results indexed on Pub Med

Learn more about this trial

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

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