Trial Outcomes & Findings for Tube Versus Trabeculectomy (TVT) Study (NCT NCT00306852)
NCT ID: NCT00306852
Last Updated: 2015-11-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
212 participants
Primary outcome timeframe
Baseline to 5 years
Results posted on
2015-11-25
Participant Flow
Participant milestones
| Measure |
Trabeculectomy
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
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
107
|
|
Overall Study
COMPLETED
|
76
|
69
|
|
Overall Study
NOT COMPLETED
|
29
|
38
|
Reasons for withdrawal
| Measure |
Trabeculectomy
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
|
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)
|
|---|---|---|
|
Overall Study
Death
|
14
|
14
|
|
Overall Study
Lost to Follow-up
|
15
|
24
|
Baseline Characteristics
Tube Versus Trabeculectomy (TVT) Study
Baseline characteristics by cohort
| Measure |
Trabeculectomy
n=105 Participants
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
|
Implant
n=107 Participants
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
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
70.9 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
71.0 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Intra-ocular pressure (IOP)
|
25.6 mm Hg
STANDARD_DEVIATION 503 • n=5 Participants
|
25.1 mm Hg
STANDARD_DEVIATION 5.3 • n=7 Participants
|
25.3 mm Hg
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
GLAUCOMA MEDICATIONS
|
3.0 number of medications used
STANDARD_DEVIATION 1.2 • n=5 Participants
|
3.2 number of medications used
STANDARD_DEVIATION 1.1 • n=7 Participants
|
3.1 number of medications used
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
ETDRS (Early Treatment Diabetic Retinopathy Study) VISUAL ACUITY
|
64.4 Letters
STANDARD_DEVIATION 19.6 • n=5 Participants
|
62.7 Letters
STANDARD_DEVIATION 24.1 • n=7 Participants
|
63.6 Letters
STANDARD_DEVIATION 21.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 5 yearsPopulation: Participants who completed 5 years of follow-up
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.
Outcome measures
| Measure |
Trabeculectomy
n=63 Participants
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
|
Implant
n=61 Participants
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)
|
|---|---|---|
|
Change in Intraocular Pressure
|
12.6 mm Hg
Standard Deviation 5.9
|
14.4 mm Hg
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: 5 yearsComplications associated with both surgical procedures
Outcome measures
| Measure |
Trabeculectomy
n=105 Participants
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
|
Implant
n=105 Participants
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)
|
|---|---|---|
|
Rate of Complications
EARLY POSTOPERATIVE COMPLICATIONS
|
39 participants
|
33 participants
|
|
Rate of Complications
LATE POSTOPERATIVE COMPLICATIONS
|
38 participants
|
36 participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Participants who complete 5 years of follow-up
Visual acuity was measured by the total number of letters read (correctly) using a ETDRS eye chart
Outcome measures
| Measure |
Trabeculectomy
n=41 Participants
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
|
Implant
n=37 Participants
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)
|
|---|---|---|
|
Visual Acuity
PATIENTS WITH COMPLICATIONS
|
56 Letters
Standard Deviation 26
|
33 Letters
Standard Deviation 31
|
|
Visual Acuity
PATIENTS WITHOUT COMPLICATIONS
|
44 Letters
Standard Deviation 30
|
46 Letters
Standard Deviation 36
|
SECONDARY outcome
Timeframe: 5 yearsReoperations for glaucoma was defined as additional glaucoma surgery requiring a return to the operating room.
Outcome measures
| Measure |
Trabeculectomy
n=105 Participants
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
|
Implant
n=107 Participants
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)
|
|---|---|---|
|
Reoperations for Glaucoma
|
15 participants
|
20 participants
|
SECONDARY outcome
Timeframe: 5 yearsThe number of supplemental glaucoma medications required in the Implant Group and Trabeculectomy Group at 5 years
Outcome measures
| Measure |
Trabeculectomy
n=105 Participants
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
|
Implant
n=107 Participants
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)
|
|---|---|---|
|
Need for Supplemental Medical Therapy
|
1.2 number of medications
Standard Deviation 1.5
|
1.4 number of medications
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 5 yearsFailure 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.
Outcome measures
| Measure |
Trabeculectomy
n=105 Participants
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
|
Implant
n=107 Participants
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)
|
|---|---|---|
|
Failure Rate
|
46.9 percentage of participants
|
29.8 percentage of participants
|
Adverse Events
Trabeculectomy
Serious events: 13 serious events
Other events: 77 other events
Deaths: 0 deaths
Implant
Serious events: 15 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trabeculectomy
n=105 participants at risk
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
|
Implant
n=107 participants at risk
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)
|
|---|---|---|
|
General disorders
CANCER
|
1.9%
2/105
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.95%
1/105
|
0.00%
0/107
|
|
Vascular disorders
STROKE
|
0.95%
1/105
|
0.93%
1/107
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/105
|
0.93%
1/107
|
|
General disorders
UNKNOWN CAUSE OF DEATH
|
6.7%
7/105
|
5.6%
6/107
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/105
|
0.93%
1/107
|
|
Respiratory, thoracic and mediastinal disorders
LUNG CANCER
|
0.95%
1/105
|
0.00%
0/107
|
|
Musculoskeletal and connective tissue disorders
BONE CANCER
|
0.00%
0/105
|
0.93%
1/107
|
|
Cardiac disorders
MYCARDIAL INFRACTION
|
0.00%
0/105
|
3.7%
4/107
|
|
Surgical and medical procedures
CORONARY ARTERY BYPASS SURGERY
|
0.00%
0/105
|
0.93%
1/107
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE TRACHEA
|
0.95%
1/105
|
0.00%
0/107
|
Other adverse events
| Measure |
Trabeculectomy
n=105 participants at risk
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
|
Implant
n=107 participants at risk
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)
|
|---|---|---|
|
Eye disorders
CHOROIDAL EFFUSION
|
17.1%
18/105
|
15.9%
17/107
|
|
Eye disorders
SHALLOW OR FLAT ANTERIOR CHAMBER
|
9.5%
10/105
|
11.2%
12/107
|
|
Eye disorders
WOUND LEAK
|
11.4%
12/105
|
0.93%
1/107
|
|
Eye disorders
HYPHEMA
|
7.6%
8/105
|
1.9%
2/107
|
|
Eye disorders
AQUEOUS MISDIRECTION
|
0.95%
1/105
|
2.8%
3/107
|
|
Eye disorders
SUPRACHOROIDAL HEMORRHAGE
|
2.9%
3/105
|
1.9%
2/107
|
|
Eye disorders
VITREOUS HEMORRHAGE
|
0.95%
1/105
|
0.93%
1/107
|
|
Eye disorders
DECOMPRESSION RETINOPATHY
|
0.95%
1/105
|
0.00%
0/107
|
|
Eye disorders
CYSTOID MACULAR EDEMA
|
2.9%
3/105
|
4.7%
5/107
|
|
Eye disorders
PERSISTENT CORNEAL EDEMA
|
8.6%
9/105
|
15.9%
17/107
|
|
Eye disorders
DYSESTHESIA
|
7.6%
8/105
|
0.93%
1/107
|
|
Eye disorders
PERSISTENT DIPLOPIA
|
1.9%
2/105
|
5.6%
6/107
|
|
Eye disorders
ENCAPSULATED BLEB
|
5.7%
6/105
|
1.9%
2/107
|
|
Eye disorders
BLEB LEAK
|
5.7%
6/105
|
0.00%
0/107
|
|
Eye disorders
HYPOTONY MACULOPATHY
|
4.8%
5/105
|
0.93%
1/107
|
|
Eye disorders
TUBE EROSION
|
—
0/0
|
4.7%
5/107
|
|
Eye disorders
ENDOPHTHALMITIS/BLEBITIS
|
4.8%
5/105
|
0.93%
1/107
|
|
Eye disorders
CHRONIC OR RECURRENT IRITIS
|
0.95%
1/105
|
1.9%
2/107
|
|
Eye disorders
TUBE OBSTRUCTION
|
—
0/0
|
5.6%
6/107
|
|
Eye disorders
RETINAL DETACHMENT
|
0.95%
1/105
|
0.93%
1/107
|
|
Eye disorders
CORNEAL ULCER
|
0.95%
1/105
|
0.00%
0/107
|
|
Eye disorders
SERIOUS COMPLICATIONS
|
20.0%
21/105
|
22.4%
24/107
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place