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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT00444080
First received: March 5, 2007
Last updated: February 1, 2013
Last verified: February 2013

March 5, 2007
February 1, 2013
October 2006
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • Safety - Post operative safety profile defined as vitreous loss and hypotony (IOP≤5mmHg) and related complications (choroidal effusion, hyphema, shallow/flat AC, leaking bleb).
  • 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.
Complete list of historical versions of study NCT00444080 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety - Comparison of the incidence of all adverse events that occur during the intra-operative and postoperative periods between the two study arms.
  • 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
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
  • Procedure: 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.
  • Device: 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.
  • Active Comparator: Control Arm
    Subjects undergoing trabeculectomy with the use of Mitomycin C
    Intervention: Procedure: Trabeculectomy
  • Experimental: Treatment Arm
    Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
    Intervention: Device: Ex-PRESS mini shunt

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00444080
14967
No
University of Virginia
University of Virginia
Not Provided
Principal Investigator: Peter A. Netland, MD, PhD University of Virginia
University of Virginia
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP