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Primary Tube Versus Trabeculectomy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00666237
Recruitment Status : Active, not recruiting
First Posted : April 24, 2008
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
Abbott Medical Optics
Research to Prevent Blindness
National Eye Institute (NEI)
Information provided by (Responsible Party):
Steven J. Gedde, University of Miami

Tracking Information
First Submitted Date  ICMJE April 23, 2008
First Posted Date  ICMJE April 24, 2008
Last Update Posted Date June 5, 2019
Study Start Date  ICMJE April 2008
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
Intraocular pressure [ Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 3 years, 4 years, 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00666237 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
  • Complication rates [ Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 3 years, 4 years, 5 years ]
  • Visual acuity [ Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 3 years, 4 years, 5 years ]
  • Visual field [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
  • Reoperation for glaucoma [ Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 3 years, 4 years, 5 years ]
  • Supplemental medical therapy [ Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 3 years, 4 years, 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Primary Tube Versus Trabeculectomy Study
Official Title  ICMJE Primary Tube Versus Trabeculectomy Study
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.
Detailed Description

Glaucoma surgery is indicated when further intraocular pressure (IOP) lowering is needed despite the use of maximum tolerated medical therapy and appropriate laser treatment. Trabeculectomy (or guarded filtration procedure) is the most frequently performed glaucoma opertion. Eyes with previous ocular surgery and certain secondary glaucomas (e.g. neovascular glaucoma and uveitic glaucoma) are at greater risk of trabeculectomy failure. Wound healing modulation with antifibrotic agents, like mitomycin C (MMC) and 5-fluorouracil (5-FU), has been shown to increase the success of glaucoma filtering surgery in high risk eyes. The use of MMC and 5-FU has become widespread in clinical practice. The improved efficacy of trabeculectomy with an adjunctive antifibrotic agent in high risk eyes has prompted their use in eyes considered to be at low risk for failure. A randomized clinical trial found similar IOP reduction and surgical complications with the intraoperative application of MMC and 5-FU in eyes undergoing primary trabeculectomy.

Although antifibrotic agents have increased the likelihood of IOP control following glaucoma filtering surgery, they have also increased the risk of complications. The prevalence of bleb-related infections, bleb leaks, and bleb dysesthesia associated with a perilimbal filtering bleb suggests the need to consider alternative surgical approaches. Favorable results have been reported with tube shunts (or glaucoma drainage implants), and these devices have been growing in popularity. In particular, the large surface area of the Baerveldt glaucoma implant combined with its ease of insertion in a single quadrant offers an advantage over other tube shunts. Similar surgical results have been reported with tube shunts and trabeculectomy with MMC or 5-FU when studied separately in similar patient groups. A comparable rate of serious complications has also been reported for the Baerveldt implant and trabeculectomy with an antifibrotic agent in a retrospective study.

The Tube Versus Trabeculectomy (TVT) Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery using the Baerveldt glaucoma implant and trabeculectomy with MMC in 212 patients with previous ocular surgery. Tube shunt surgery was more likely to maintain IOP control and avoid persistent hypotony or reoperation for glaucoma than trabeculectomy with MMC during the first year of follow-up in the TVT Study. Tube shunt surgery and trabeculectomy with MMC produced similar IOP reduction at 1 year, but there was less need for supplemental medical therapy following trabeculectomy. There were a large number of surgical complications during the first year of follow-up in the TVT Study, but most were transient and self-limited. The incidence of postoperative complications was higher following trabeculectomy with MMC than tube shunt surgery. However, severe complications resulting in reoperation and/or vision loss occurred with similar frequency with both surgical procedures. Vision loss occurred at a similar rate following tube shunt surgery and trabeculectomy with MMC. Patients who experienced surgical complications had greater vision loss than patients without complications.

The results of the TVT Study suggest the need to compare the safety and efficacy of tube shunt surgery and trabeculectomy with MMC in patients at low risk of surgical failure, including eyes without previous ocular surgery. The Primary Tube Versus Trabeculectomy (PTVT) Study is a multicenter randomized clinical trial that is similar in design to the TVT Study. Enrolled patients are randomized to undergo placement of a 350mm2 Baerveldt glaucoma implant or trabeculectomy with MMC. Baseline characteristics of the study population will be tabulated for each treatment group. Outcome discrimination between the two treatment groups will include IOP, surgical complications, visual acuity, visual fields, glaucoma reoperation, and need for supplemental medical therapy. Data will be collected at the normal postoperative visits at 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 3 years, 4 years, and 5 years after surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • Procedure: Tube shunt surgery
    350mm2 Baerveldt glaucoma implant
  • Procedure: Trabeculectomy with mitomycin C
    Mitomycin C 0.4 mg/ml for 2 minutes
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Procedure: Tube shunt surgery
  • Active Comparator: 2
    Intervention: Procedure: Trabeculectomy with mitomycin C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 10, 2017)
242
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2008)
250
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00666237
Other Study ID Numbers  ICMJE 20071037
NEI Grant No. EY014801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven J. Gedde, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE
  • Abbott Medical Optics
  • Research to Prevent Blindness
  • National Eye Institute (NEI)
Investigators  ICMJE
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
PRS Account University of Miami
Verification Date June 2019

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