Primary Tube Versus Trabeculectomy Study

This study is currently recruiting participants.
Verified August 2009 by Bascom Palmer Eye Institute
Sponsor:
Collaborators:
Abbott Medical Optics
Research to Prevent Blindness
Information provided by:
Bascom Palmer Eye Institute
ClinicalTrials.gov Identifier:
NCT00666237
First received: April 23, 2008
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

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 Intervention
Glaucoma
Procedure: Tube shunt surgery
Procedure: Trabeculectomy with mitomycin C

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Tube Versus Trabeculectomy Study

Resource links provided by NLM:


Further study details as provided by Bascom Palmer Eye Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Visual field [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: April 2008
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: Tube shunt surgery
350mm2 Baerveldt glaucoma implant
Active Comparator: 2 Procedure: Trabeculectomy with mitomycin C
Mitomycin C 0.4 mg/ml for 2 minutes

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666237

Contacts
Contact: Steven J Gedde, MD 305-326-6435 sgedde@med.miami.edu
Contact: Joyce C Schiffman, MS 305-243-5487 jschiffman@med.miami.edu

Locations
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Steven J Gedde, MD    305-326-6435    sgedde@med.miami.edu   
Sub-Investigator: Donald L Budenz, MD         
Sub-Investigator: Francisco E Fantes, MD         
Sub-Investigator: William J Feuer, MS         
Sub-Investigator: Elizabeth Hodapp, MD         
Sub-Investigator: Richard K Lee, MD, PhD         
Sub-Investigator: Paul F Palmberg, MD, PhD         
Sub-Investigator: Richard K Parrish, MD         
Sub-Investigator: Joyce C Schiffman, MS         
Principal Investigator: Steven J Gedde, MD         
United States, New York
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Contact: Paul Sidoti, MD    212-979-4590    psidoti@nyee.edu   
Principal Investigator: Paul Sidoti, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Husam Ansari, MD, PhD    215-662-8140    husam.ansari@uphs.upenn.edu   
Principal Investigator: Husam Ansari, MD, PhD         
Sub-Investigator: Connie Okeke, MD         
Sub-Investigator: Eydie Miller, MD         
United States, Texas
University of Texas, Houston Recruiting
Houston, Texas, United States, 77030
Contact: Robert Feldman, MD    713-798-5945    rmfeldman@swbell.net   
Principal Investigator: Robert Feldman, MD         
Sub-Investigator: Nicholas Bell, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Bruce Prum, MD    434-924-2808    bep2z@virginia.edu   
Principal Investigator: Bruce Prum, MD         
Sponsors and Collaborators
Bascom Palmer Eye Institute
Abbott Medical Optics
Research to Prevent Blindness
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
  More Information

No publications provided

Responsible Party: Steven J. Gedde, M.D., Bascom Palmer Eye Institute
ClinicalTrials.gov Identifier: NCT00666237     History of Changes
Other Study ID Numbers: 20071037, NEI Grant No. EY014801
Study First Received: April 23, 2008
Last Updated: August 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Bascom Palmer Eye Institute:
Glaucoma
Tube shunt surgery
Trabeculectomy

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on April 22, 2014