Tube Versus Trabeculectomy (TVT) Study

Sponsor
University of Miami (Other)
Overall Status
Completed
CT.gov ID
NCT00306852
Collaborator
Pfizer (Industry), Abbott Medical Optics (Industry)
212
17
2
115
12.5
0.1

Study Details

Study Description

Brief Summary

The purpose of the Tube Versus Trabeculectomy (TVT) Study is to compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous ocular surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Baerveldt implant
  • Procedure: Trabeculectomy with mitomycin C
N/A

Detailed Description

Glaucoma surgery is performed when further intraocular pressure (IOP) reduction is needed despite the use of maximum tolerated medical therapy and appropriate laser treatment. Trabeculectomy is generally used as the initial incisional surgical procedure in managing glaucoma. However, eyes in which trabeculectomy has failed are at greater risk of failure with subsequent filtering surgery. Wound modulation with antifibrotic agents, like mitomycin C (MMC) and 5-fluorouracil (5-FU), has been shown to increase the success rate of trabeculectomy in eyes that have undergone previous ocular surgery. Although antifibrotic agents have increased the likelihood of IOP control following filtering surgery, they have also increased the risk of complications. The prevalence of bleb leaks, bleb-related infections, and bleb dysesthesia associated with a perilimbal filtering bleb suggests the need to consider alternatives. Tube shunts (or glaucoma drainage implants) offer an alternative to trabeculectomy in the surgical management of glaucoma, and these devices have been growing in popularity in recent years.

Practice patterns vary in the surgical management of glaucoma in eyes with previous ocular surgery. In 1996, Chen and colleagues conducted an anonymous survey of members of the American Glaucoma Society (AGS) and Japanese Glaucoma Society (JGS) to evaluate use of antifibrotic agents and tube shunts. The survey presented ten clinical situations requiring glaucoma surgical intervention. The majority of respondents (59-83%) preferred trabeculectomy with MMC for the clinical scenarios involving prior ocular surgery, although many of those surveyed elected to use a tube shunt, trabeculectomy with 5-FU, or trabeculectomy without an antifibrotic agent. In 2002, Joshi and associates re-administered the same survey to members of the AGS. Respondents still favored trabeculectomy with MMC, but the percentage usage of tube shunts had significantly increased. The greatest practice pattern shift was observed in patients with previous cataract and glaucoma surgery. In particular, selection of tube shunts as the preferred surgical approach increased from 7% to 22% in eyes with prior trabeculectomy, and increased from 8% to 22% in eyes with prior extracapsular or intracapsular cataract extraction.

The lack of consensus among glaucoma surgeons regarding the use of tube shunts or trabeculectomy with an antifibrotic agent in eyes that have had prior cataract or glaucoma surgery likely relates to the fact that available clinical data has not shown one surgical procedure to be superior to the other. Similar surgical results have been reported with both glaucoma procedures in eyes with aphakia/pseudophakia and failed filters when studied separately. Success rates have ranged from 50% to 88% for tube shunts, and 48% to 86% for filtering surgery with an antifibrotic agent in case series studying aphakic/pseudophakic eyes. Success rates have ranged from 44% to 88% for tube shunts, and 61% to 100% for 5-FU and MMC trabeculectomy in eyes with failed filters. Comparable rates of severe complications have also been reported with tube shunt surgery and trabeculectomy with an adjunctive antifibrotic agent.

The Tube Versus Trabeculectomy (TVT) Study was designed to prospectively compare the safety and efficacy of nonvalved tube shunt surgery and trabeculectomy with MMC. Patients with uncontrolled glaucoma who had prior cataract extraction with intraocular lens implantation and/or failed filtering surgery were enrolled in this multicenter clinical trial and randomized to placement of a 350 Baerveldt glaucoma implant (Advanced Medical Optics, Irvine, CA) or trabeculectomy with MMC (0.4 mg/ml for 4 minutes). The goal of this investigator initiated trial is to provide information that will assist in surgical decision-making in similar patient groups.

Study Design

Study Type:
Interventional
Actual Enrollment :
212 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Tube Versus Trabeculectomy (TVT) Study
Study Start Date :
Oct 1, 1999
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Trabeculectomy

Trabeculectomy with mitomycin C

Procedure: Trabeculectomy with mitomycin C
Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant

Active Comparator: Implant

Baerveldt Implant

Procedure: Baerveldt implant
Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)

Outcome Measures

Primary Outcome Measures

  1. Change in Intraocular Pressure [Baseline to 5 years]

    The data value from the Baseline visit and 5 year follow-up visit were combined. Specifically, values were calculated by subtracting the 5 Year Intraocular Pressure from the Baseline Intraocular Pressure.

  2. Rate of Complications [5 years]

    Complications associated with both surgical procedures

Secondary Outcome Measures

  1. Visual Acuity [5 years]

    Visual acuity was measured by the total number of letters read (correctly) using a ETDRS eye chart

  2. Reoperations for Glaucoma [5 years]

    Reoperations for glaucoma was defined as additional glaucoma surgery requiring a return to the operating room.

  3. Need for Supplemental Medical Therapy [5 years]

    The number of supplemental glaucoma medications required in the Implant Group and Trabeculectomy Group at 5 years

  4. Failure Rate [5 years]

    Failure was prospectively defined as IOP greater than 21 mm Hg or less than 20 percent reduction below baseline on 2 consecutive follow-up visits after 3 months, IOP less than or equal to 5 mm Hg on 2 consecutive follow-up visits after 3 months, re-operation for glaucoma, or loss of light perception vision.

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 to 85 years

  • Intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg

  • Previous trabeculectomy, cataract extraction with intraocular lens implantation, or both

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 downgrowth

  • Aphakia

  • Vitreous in the anterior chamber for which a vitrectomy is anticipated

  • Chronic or recurrent uveitis

  • Severe posterior blepharitis

  • Unwilling to discontinue contact lens use after surgery

  • Previous cyclodestructive procedure, scleral buckling procedure, or presence of silicone oil

  • Conjunctival scarring precluding a trabeculectomy superiorly

  • Need for glaucoma surgery combined with other ocular procedures (eg cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scripps Clinic La Jolla California United States 92036
2 University of Southern California Los Angeles California United States 90033
3 University of California Davis Sacramento California United States 95817
4 University of Florida Gainesville Florida United States 32610
5 Bascom Palmer Eye Institute Miami Florida United States 33136
6 Loyola University Maywood Illinois United States 60153
7 Indiana University Indianapolis Indiana United States 46202
8 St. Louis University St. Louis Missouri United States 63104
9 New York Eye and Ear Infirmary New York New York United States 10003
10 Duke University Durham North Carolina United States 27710
11 University of Oklahoma Oklahoma City Oklahoma United States 73104
12 Medical University of South Carolina Charleston South Carolina United States 29425
13 University of Texas Houston Houston Texas United States 77030
14 University of Virginia Charlottesville Virginia United States 22908
15 University of Wisconsin Madison Wisconsin United States 53705
16 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
17 Moorfields Eye Hospital London United Kingdom

Sponsors and Collaborators

  • University of Miami
  • Pfizer
  • Abbott Medical Optics

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Steven J. Gedde, Professor of Ophthalmology, University of Miami
ClinicalTrials.gov Identifier:
NCT00306852
Other Study ID Numbers:
  • 19990167
First Posted:
Mar 24, 2006
Last Update Posted:
Nov 25, 2015
Last Verified:
Oct 1, 2015
Keywords provided by Steven J. Gedde, Professor of Ophthalmology, University of Miami
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Trabeculectomy Implant
Arm/Group Description Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant Baerveldt Implant Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
Period Title: Overall Study
STARTED 105 107
COMPLETED 76 69
NOT COMPLETED 29 38

Baseline Characteristics

Arm/Group Title Trabeculectomy Implant Total
Arm/Group Description Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant Baerveldt Implant Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) Total of all reporting groups
Overall Participants 105 107 212
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
71.1
(9.9)
70.9
(11.0)
71.0
(10.4)
Sex: Female, Male (Count of Participants)
Female
48
45.7%
64
59.8%
112
52.8%
Male
57
54.3%
43
40.2%
100
47.2%
Intra-ocular pressure (IOP) (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]
25.6
(503)
25.1
(5.3)
25.3
(5.3)
GLAUCOMA MEDICATIONS (number of medications used) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of medications used]
3.0
(1.2)
3.2
(1.1)
3.1
(1.2)
ETDRS (Early Treatment Diabetic Retinopathy Study) VISUAL ACUITY (Letters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Letters]
64.4
(19.6)
62.7
(24.1)
63.6
(21.6)

Outcome Measures

1. Primary Outcome
Title Change in Intraocular Pressure
Description The data value from the Baseline visit and 5 year follow-up visit were combined. Specifically, values were calculated by subtracting the 5 Year Intraocular Pressure from the Baseline Intraocular Pressure.
Time Frame Baseline to 5 years

Outcome Measure Data

Analysis Population Description
Participants who completed 5 years of follow-up
Arm/Group Title Trabeculectomy Implant
Arm/Group Description Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant Baerveldt Implant Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
Measure Participants 63 61
Mean (Standard Deviation) [mm Hg]
12.6
(5.9)
14.4
(6.9)
2. Primary Outcome
Title Rate of Complications
Description Complications associated with both surgical procedures
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Trabeculectomy Implant
Arm/Group Description Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant Baerveldt Implant Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
Measure Participants 105 105
EARLY POSTOPERATIVE COMPLICATIONS
39
37.1%
33
30.8%
LATE POSTOPERATIVE COMPLICATIONS
38
36.2%
36
33.6%
3. Secondary Outcome
Title Visual Acuity
Description Visual acuity was measured by the total number of letters read (correctly) using a ETDRS eye chart
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
Participants who complete 5 years of follow-up
Arm/Group Title Trabeculectomy Implant
Arm/Group Description Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant Baerveldt Implant Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
Measure Participants 41 37
PATIENTS WITH COMPLICATIONS
56
(26)
33
(31)
PATIENTS WITHOUT COMPLICATIONS
44
(30)
46
(36)
4. Secondary Outcome
Title Reoperations for Glaucoma
Description Reoperations for glaucoma was defined as additional glaucoma surgery requiring a return to the operating room.
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Trabeculectomy Implant
Arm/Group Description Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant Baerveldt Implant Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
Measure Participants 105 107
Number [participants]
15
14.3%
20
18.7%
5. Secondary Outcome
Title Need for Supplemental Medical Therapy
Description The number of supplemental glaucoma medications required in the Implant Group and Trabeculectomy Group at 5 years
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Trabeculectomy Implant
Arm/Group Description Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant Baerveldt Implant Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
Measure Participants 105 107
Mean (Standard Deviation) [number of medications]
1.2
(1.5)
1.4
(1.3)
6. Secondary Outcome
Title Failure Rate
Description Failure was prospectively defined as IOP greater than 21 mm Hg or less than 20 percent reduction below baseline on 2 consecutive follow-up visits after 3 months, IOP less than or equal to 5 mm Hg on 2 consecutive follow-up visits after 3 months, re-operation for glaucoma, or loss of light perception vision.
Time Frame 5 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Trabeculectomy Implant
Arm/Group Description Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant Baerveldt Implant Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
Measure Participants 105 107
Number [percentage of participants]
46.9
44.7%
29.8
27.9%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Trabeculectomy Implant
Arm/Group Description Trabeculectomy with mitomycin C Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant Baerveldt Implant Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
All Cause Mortality
Trabeculectomy Implant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Trabeculectomy Implant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 13/105 (12.4%) 15/107 (14%)
Cardiac disorders
MYCARDIAL INFRACTION 0/105 (0%) 4/107 (3.7%)
General disorders
CANCER 2/105 (1.9%) 0/107 (0%)
UNKNOWN CAUSE OF DEATH 7/105 (6.7%) 6/107 (5.6%)
Metabolism and nutrition disorders
DEHYDRATION 0/105 (0%) 1/107 (0.9%)
Musculoskeletal and connective tissue disorders
BONE CANCER 0/105 (0%) 1/107 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE TRACHEA 1/105 (1%) 0/107 (0%)
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1/105 (1%) 0/107 (0%)
RESPIRATORY FAILURE 0/105 (0%) 1/107 (0.9%)
LUNG CANCER 1/105 (1%) 0/107 (0%)
Surgical and medical procedures
CORONARY ARTERY BYPASS SURGERY 0/105 (0%) 1/107 (0.9%)
Vascular disorders
STROKE 1/105 (1%) 1/107 (0.9%)
Other (Not Including Serious) Adverse Events
Trabeculectomy Implant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 77/105 (73.3%) 58/107 (54.2%)
Eye disorders
CHOROIDAL EFFUSION 18/105 (17.1%) 17/107 (15.9%)
SHALLOW OR FLAT ANTERIOR CHAMBER 10/105 (9.5%) 12/107 (11.2%)
WOUND LEAK 12/105 (11.4%) 1/107 (0.9%)
HYPHEMA 8/105 (7.6%) 2/107 (1.9%)
AQUEOUS MISDIRECTION 1/105 (1%) 3/107 (2.8%)
SUPRACHOROIDAL HEMORRHAGE 3/105 (2.9%) 2/107 (1.9%)
VITREOUS HEMORRHAGE 1/105 (1%) 1/107 (0.9%)
DECOMPRESSION RETINOPATHY 1/105 (1%) 0/107 (0%)
CYSTOID MACULAR EDEMA 3/105 (2.9%) 5/107 (4.7%)
PERSISTENT CORNEAL EDEMA 9/105 (8.6%) 17/107 (15.9%)
DYSESTHESIA 8/105 (7.6%) 1/107 (0.9%)
PERSISTENT DIPLOPIA 2/105 (1.9%) 6/107 (5.6%)
ENCAPSULATED BLEB 6/105 (5.7%) 2/107 (1.9%)
BLEB LEAK 6/105 (5.7%) 0/107 (0%)
HYPOTONY MACULOPATHY 5/105 (4.8%) 1/107 (0.9%)
TUBE EROSION 0/0 (NaN) 5/107 (4.7%)
ENDOPHTHALMITIS/BLEBITIS 5/105 (4.8%) 1/107 (0.9%)
CHRONIC OR RECURRENT IRITIS 1/105 (1%) 2/107 (1.9%)
TUBE OBSTRUCTION 0/0 (NaN) 6/107 (5.6%)
RETINAL DETACHMENT 1/105 (1%) 1/107 (0.9%)
CORNEAL ULCER 1/105 (1%) 0/107 (0%)
SERIOUS COMPLICATIONS 21/105 (20%) 24/107 (22.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Steven Gedde
Organization University of Miami
Phone 305-326-6435
Email sgedde@med.miami.edu
Responsible Party:
Steven J. Gedde, Professor of Ophthalmology, University of Miami
ClinicalTrials.gov Identifier:
NCT00306852
Other Study ID Numbers:
  • 19990167
First Posted:
Mar 24, 2006
Last Update Posted:
Nov 25, 2015
Last Verified:
Oct 1, 2015