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The Asia Primary Tube Versus Trab (TVT) Study (TVT)

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Ahmed Glaucoma Implant
Trabeculectomy with Mitomycin C
Sponsored by
Singapore Eye Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma.
  2. IOP > 18 mm Hg on 2 or more medications on at least 2 visits
  3. Informed consent given and consent form signed.

Exclusion Criteria:

  1. Unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits.
  2. Pregnant or nursing women
  3. No light perception vision
  4. Previous incisional intraocular surgery, other than uncomplicated clear corneal cataract surgery
  5. Previous ocular laser in study eye (keratorefractive surgery and cyclodestructive procedure), except for laser trabeculoplasty procedures (Argon Laser and Selective Laser Trabeculoplasty)
  6. Iris neovascularisation or proliferative retinopathy
  7. Primary angle closure or primary angle closure glaucoma
  8. Iridocorneal endothelial syndrome or anterior segment dysgenesis
  9. Epithelial or fibrous downgrowth
  10. Aphakia
  11. Chronic or recurrent uveitis
  12. Severe posterior blepharitis
  13. Unwilling to discontinue contact lens use after surgery
  14. Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery or neovascular disease
  15. Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy
  16. Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery
  17. Advanced glaucoma with MD <-20dB

Sites / Locations

  • Singapore Eye Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tube implant

Trabeculectomy

Arm Description

Ahmed Glaucoma Implant (AGI) surgery

Trabeculectomy with mitomycin C surgery

Outcomes

Primary Outcome Measures

Failure
Failure defined by ANY of the following criteria: IOP ≥ 18 mm Hg on two consecutive follow-up visits after 6 months IOP not reduced to 20% below baseline on two consecutive visits after 6 months IOP ≤ 5 mm Hg with visually significant hypotony maculopathy on two consecutive visits after 3 months Additional glaucoma surgery, excluding laser suture lysis, removal of releasable trabeculectomy or conjunctival sutures, needling of the bleb or tube plate with or without 5FU, subconjunctival 5FU injections and anterior chamber reformation. Loss of light perception vision

Secondary Outcome Measures

IOP
Intraocular pressure (mmHg)
Best Corrected Visual Acuity (BCVA)
ETDRS visual acuity chart (logMAR or equivalent)
Supplemental medication
Number of supplemental glaucoma medications used at Month 60
Adverse Events
Number of Adverse Events during the trial

Full Information

First Posted
August 29, 2017
Last Updated
September 5, 2017
Sponsor
Singapore Eye Research Institute
Collaborators
National Medical Research Council (NMRC), Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03274024
Brief Title
The Asia Primary Tube Versus Trab (TVT) Study
Acronym
TVT
Official Title
The Asia Primary Tube Versus Trab (TVT) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 28, 2016 (Actual)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore Eye Research Institute
Collaborators
National Medical Research Council (NMRC), Singapore

4. Oversight

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

5. Study Description

Brief Summary
Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in patients with uncontrolled open angle glaucoma
Detailed Description
The objective of the Asia Primary Tube versus Trab (TVT) study is to compare the efficacy and safety of placement of an Ahmed Glaucoma Implant (AGI) (New World Medical Inc., Rancho Cucamonga, CA, USA) against trabeculectomy with mitomycin C in patients with uncontrolled glaucoma, who may or may not have had previous clear corneal cataract surgery with intraocular lens implantation, over 5 years. Outcome discrimination between the two treatment groups will be made using following parameters: Intraocular pressure Need for supplemental medical therapy Incidence of short and long term surgical complications and need for re-operation. Visual function (Visual acuity and Visual field) Hypothesis: Glaucoma drainage implants have better surgical outcomes in terms of IOP lowering efficacy compared to trabeculectomy with mitomycin-C over 5 years in Asian patients with medically uncontrolled glaucoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tube implant
Arm Type
Experimental
Arm Description
Ahmed Glaucoma Implant (AGI) surgery
Arm Title
Trabeculectomy
Arm Type
Active Comparator
Arm Description
Trabeculectomy with mitomycin C surgery
Intervention Type
Device
Intervention Name(s)
Ahmed Glaucoma Implant
Intervention Description
Conjunctival Flap Scleral Exposure Insertion of Episcleral Plate Priming of the tube prior to AC entrance Insertion of Tube into the Anterior Chamber Suturing tube Coverage of tube
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy with Mitomycin C
Intervention Description
Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure
Primary Outcome Measure Information:
Title
Failure
Description
Failure defined by ANY of the following criteria: IOP ≥ 18 mm Hg on two consecutive follow-up visits after 6 months IOP not reduced to 20% below baseline on two consecutive visits after 6 months IOP ≤ 5 mm Hg with visually significant hypotony maculopathy on two consecutive visits after 3 months Additional glaucoma surgery, excluding laser suture lysis, removal of releasable trabeculectomy or conjunctival sutures, needling of the bleb or tube plate with or without 5FU, subconjunctival 5FU injections and anterior chamber reformation. Loss of light perception vision
Time Frame
6 months
Secondary Outcome Measure Information:
Title
IOP
Description
Intraocular pressure (mmHg)
Time Frame
60 months
Title
Best Corrected Visual Acuity (BCVA)
Description
ETDRS visual acuity chart (logMAR or equivalent)
Time Frame
60 months
Title
Supplemental medication
Description
Number of supplemental glaucoma medications used at Month 60
Time Frame
60 months
Title
Adverse Events
Description
Number of Adverse Events during the trial
Time Frame
60 months

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: Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma. IOP > 18 mm Hg on 2 or more medications on at least 2 visits Informed consent given and consent form signed. Exclusion Criteria: Unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits. Pregnant or nursing women No light perception vision Previous incisional intraocular surgery, other than uncomplicated clear corneal cataract surgery Previous ocular laser in study eye (keratorefractive surgery and cyclodestructive procedure), except for laser trabeculoplasty procedures (Argon Laser and Selective Laser Trabeculoplasty) Iris neovascularisation or proliferative retinopathy Primary angle closure or primary angle closure glaucoma Iridocorneal endothelial syndrome or anterior segment dysgenesis Epithelial or fibrous downgrowth Aphakia Chronic or recurrent uveitis Severe posterior blepharitis Unwilling to discontinue contact lens use after surgery Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery or neovascular disease Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery Advanced glaucoma with MD <-20dB
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Porporato, Fellow
Phone
+6591378217
Email
natalia.porporato@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ya Ying Ooi
Phone
+658186 7051
Email
ooi.ya.ying@seri.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching Lin Ho
Organizational Affiliation
Singapore National Eye Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore Eye Research Institute
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serena Ting
Phone
(+65) 8113 5026
Email
serena.ting.m.l@seri.com.sg
First Name & Middle Initial & Last Name & Degree
Ching Lin Ho, A/Prof

12. IPD Sharing Statement

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The Asia Primary Tube Versus Trab (TVT) Study

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