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Primary Tube Versus Trabeculectomy Study

Sponsor
University of Miami (Other)
Overall Status
Completed
CT.gov ID
NCT00666237
Collaborator
Abbott Medical Optics (Industry), Research to Prevent Blindness (Other), National Eye Institute (NEI) (NIH)
242
Enrollment
16
Locations
2
Arms
156
Actual Duration (Months)
15.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tube shunt surgery
  • Procedure: Trabeculectomy
  • Drug: Mitomycin C
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Primary Tube Versus Trabeculectomy Study
Actual Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tube shunt surgery group

Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).

Procedure: Tube shunt surgery
The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
Other Names:
  • Baerveldt glaucoma implant

    		•
    Experimental: Trabeculectomy with Mitomycin C

    Participants in this group will receive a Trabeculectomy surgery with Mitomycin C

    Procedure: Trabeculectomy
    The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.

    Drug: Mitomycin C
    A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular pressure [Up to 5 years]

      Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen.

    Secondary Outcome Measures

    1. Complication rates [Up to 5 years]

      Percentage of participants with reported complications from intervention will be reported

    2. Visual acuity using a Snellen Chart [Up to 5 years]

      Visual acuity will be measured using different sized letters on a Snellen chart

    3. Visual acuity using an EDTRS chart [Up to 5 years]

      Visual acuity will be measured using different sized letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

    4. Visual field [Up to 5 years]

      Visual fields will be measured using standard automated perimetry.

    5. Reoperation for glaucoma [Up to 5 years]

      The number of participants requiring reoperation for glaucoma will be reported

    6. Supplemental medical therapy [Up to 5 years]

      The number of participants requiring supplemental medical therapy for glaucoma will be reported

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18-85 years

    • Glaucoma that is inadequately controlled on tolerated medical therapy with IOP greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg

    • No previous incisional ocular surgery

    Exclusion Criteria:

    • Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits

    • Pregnant or nursing women

    • No light perception vision

    • Active iris neovascularization or active proliferative retinopathy

    • Iridocorneal endothelial syndrome

    • Epithelial or fibrous ingrowth

    • Chronic or recurrent uveitis

    • Steroid-induced glaucoma

    • Severe posterior blepharitis

    • Unwilling to discontinue contact lens use after surgery

    • Previous cyclodestructive procedure

    • Conjunctival scarring from prior ocular trauma or cicatrizing disease precluding a superior trabeculectomy

    • Functionally significant cataract

    • Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California Davis Medical Center Sacramento California United States 95817
    2 University of Florida Gainesville Florida United States 32610
    3 Bascom Palmer Eye Institute Miami Florida United States 33136
    4 Johns Hopkins Baltimore Maryland United States 21290
    5 St. Louis University Saint Louis Missouri United States 63104
    6 New York Eye and Ear Infirmary New York New York United States 10003
    7 Cincinnati Eye Institute Cincinnati Ohio United States 45242
    8 University of Oklahoma Oklahoma City Oklahoma United States 73104
    9 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    10 Glaucoma Associates of Texas Dallas Texas United States 75231
    11 University of Texas, Houston Houston Texas United States 77030
    12 University of Virginia Charlottesville Virginia United States 22908
    13 University of Toronto Toronto Canada
    14 Moorfields Eye Hospital London United Kingdom
    15 St. Thomas' Hospital London United Kingdom
    16 Queen Mary's Sidcup Hospital Sidcup United Kingdom

    Sponsors and Collaborators

    • University of Miami
    • Abbott Medical Optics
    • Research to Prevent Blindness
    • National Eye Institute (NEI)

    Investigators

    • Study Chair: Steven J Gedde, MD, Bascom Palmer Eye Institute
    • Study Chair: Dale K Heuer, MD, Medical College of Wisconsin
    • Study Chair: Richard K Parrish, MD, Bascom Palmer Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Steven J. Gedde, Dr, University of Miami
    ClinicalTrials.gov Identifier:
    NCT00666237
    Other Study ID Numbers:
    • 20071037
    • NEI Grant No. EY014801
    First Posted:
    Apr 24, 2008
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Steven J. Gedde, Dr, University of Miami
    Tube shunt surgery
    Trabeculectomy
    Additional relevant MeSH terms:
    Glaucoma
    Mitomycins
    Mitomycin

    Study Results

    No Results Posted as of May 26, 2022