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Primary Tube Versus Trabeculectomy Study

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tube shunt surgery
Trabeculectomy
Mitomycin C
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Tube shunt surgery, Trabeculectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-85 years
  • Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular Pressure (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

Sites / Locations

  • University of California Davis Medical Center
  • University of Florida
  • Bascom Palmer Eye Institute
  • Johns Hopkins
  • St. Louis University
  • New York Eye and Ear Infirmary
  • Cincinnati Eye Institute
  • University of Oklahoma
  • University of Pennsylvania
  • Glaucoma Associates of Texas
  • University of Texas, Houston
  • University of Virginia
  • University of Toronto
  • Moorfields Eye Hospital
  • St. Thomas' Hospital
  • Queen Mary's Sidcup Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tube shunt surgery group

Trabeculectomy with Mitomycin C

Arm Description

Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).

Participants in this group will receive a Trabeculectomy surgery with Mitomycin C

Outcomes

Primary Outcome Measures

Number of Participants With Surgical Failure
Surgical failure is defined as: Inadequate Intraocular Pressure (IOP) Reduction (IOP > 21 mmHg or reduced < 20% below baseline on 2 consecutive follow-up visits after 3 months) Reoperation for glaucoma Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months) Loss of light perception vision

Secondary Outcome Measures

Intraocular Pressure
Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen.
Number of Participants With Reported Postoperative Complications
Number of participants with early and late postoperative complications will be reported as per treating physician assessment
Visual Acuity Using a Snellen Chart
Visual acuity will be measured using a Snellen chart on logMAR (Logarithm of Minimal Angle of Resolution) scale. Letter-by letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Visual Acuity as Measured Using EDTRS Chart
Visual acuity will be reported as the number of correctly identified letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) chart. Total score ranges from 0-100 with the higher score indicating better visual acuity.
Visual Field
Visual fields will be measured using standard automated perimetry.
Reoperation for Glaucoma
The number of participants requiring reoperation for glaucoma will be reported
Number of Glaucoma Medications
The need for supplemental glaucoma medications will be reported as the number of glaucoma medications used

Full Information

First Posted
April 23, 2008
Last Updated
October 18, 2022
Sponsor
University of Miami
Collaborators
Abbott Medical Optics, Research to Prevent Blindness, National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00666237
Brief Title
Primary Tube Versus Trabeculectomy Study
Official Title
Primary Tube Versus Trabeculectomy Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2008 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Abbott Medical Optics, Research to Prevent Blindness, National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Tube shunt surgery, Trabeculectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tube shunt surgery group
Arm Type
Experimental
Arm Description
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Arm Title
Trabeculectomy with Mitomycin C
Arm Type
Experimental
Arm Description
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Intervention Type
Procedure
Intervention Name(s)
Tube shunt surgery
Other Intervention Name(s)
Baerveldt glaucoma implant
Intervention Description
The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy
Intervention Description
The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Intervention Description
A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
Primary Outcome Measure Information:
Title
Number of Participants With Surgical Failure
Description
Surgical failure is defined as: Inadequate Intraocular Pressure (IOP) Reduction (IOP > 21 mmHg or reduced < 20% below baseline on 2 consecutive follow-up visits after 3 months) Reoperation for glaucoma Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months) Loss of light perception vision
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Intraocular Pressure
Description
Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen.
Time Frame
At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years
Title
Number of Participants With Reported Postoperative Complications
Description
Number of participants with early and late postoperative complications will be reported as per treating physician assessment
Time Frame
Up to 5 years
Title
Visual Acuity Using a Snellen Chart
Description
Visual acuity will be measured using a Snellen chart on logMAR (Logarithm of Minimal Angle of Resolution) scale. Letter-by letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Time Frame
At Baseline, At 5 years
Title
Visual Acuity as Measured Using EDTRS Chart
Description
Visual acuity will be reported as the number of correctly identified letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) chart. Total score ranges from 0-100 with the higher score indicating better visual acuity.
Time Frame
At baseline, At 5 years
Title
Visual Field
Description
Visual fields will be measured using standard automated perimetry.
Time Frame
Up to 5 years
Title
Reoperation for Glaucoma
Description
The number of participants requiring reoperation for glaucoma will be reported
Time Frame
Up to 5 years
Title
Number of Glaucoma Medications
Description
The need for supplemental glaucoma medications will be reported as the number of glaucoma medications used
Time Frame
At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-85 years Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular Pressure (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Gedde, MD
Organizational Affiliation
Bascom Palmer Eye Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dale K Heuer, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard K Parrish, MD
Organizational Affiliation
Bascom Palmer Eye Institute
Official's Role
Study Chair
Facility Information:
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21290
Country
United States
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Glaucoma Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Toronto
City
Toronto
Country
Canada
Facility Name
Moorfields Eye Hospital
City
London
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
Country
United Kingdom
Facility Name
Queen Mary's Sidcup Hospital
City
Sidcup
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29248173
Citation
Gedde SJ, Chen PP, Heuer DK, Singh K, Wright MM, Feuer WJ, Schiffman JC, Shi W; Primary Tube Versus Trabeculectomy Study Group. The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C. Ophthalmology. 2018 May;125(5):774-781. doi: 10.1016/j.ophtha.2017.10.037. Epub 2017 Dec 18.
Results Reference
background
PubMed Identifier
31727428
Citation
Gedde SJ, Feuer WJ, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt JD; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up. Ophthalmology. 2020 Mar;127(3):333-345. doi: 10.1016/j.ophtha.2019.10.002. Epub 2019 Oct 9.
Results Reference
result
PubMed Identifier
29477688
Citation
Gedde SJ, Feuer WJ, Shi W, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt J; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. Ophthalmology. 2018 May;125(5):650-663. doi: 10.1016/j.ophtha.2018.02.003. Epub 2018 Feb 21.
Results Reference
result
PubMed Identifier
32622848
Citation
Gedde SJ, Feuer WJ, Chen PP, Heuer DK, Singh K, Wright MM; Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Study Groups. Comparing Treatment Outcomes from the Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Studies. Ophthalmology. 2021 Feb;128(2):324-326. doi: 10.1016/j.ophtha.2020.06.059. Epub 2020 Jul 2.
Results Reference
result

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Primary Tube Versus Trabeculectomy Study

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