Tube Versus Trabeculectomy (TVT) Study
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 |
---|---|---|
|
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
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
- 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.
- Rate of Complications [5 years]
Complications associated with both surgical procedures
Secondary Outcome Measures
- Visual Acuity [5 years]
Visual acuity was measured by the total number of letters read (correctly) using a ETDRS eye chart
- Reoperations for Glaucoma [5 years]
Reoperations for glaucoma was defined as additional glaucoma surgery requiring a return to the operating room.
- Need for Supplemental Medical Therapy [5 years]
The number of supplemental glaucoma medications required in the Implant Group and Trabeculectomy Group at 5 years
- 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
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.- 19990167
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
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)
|
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%
|
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)
|
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%
|
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)
|
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
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 |
sgedde@med.miami.edu |
- 19990167