The Asia Primary Tube Versus Trab (TVT) Study

Sponsor
Singapore Eye Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT03274024
Collaborator
National Medical Research Council (NMRC), Singapore (Other)
300
1
2
49.1
6.1

Study Details

Study Description

Brief Summary

Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in patients with uncontrolled open angle glaucoma

Condition or Disease Intervention/Treatment Phase
  • Device: Ahmed Glaucoma Implant
  • Procedure: Trabeculectomy with Mitomycin C
N/A

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:

  1. Intraocular pressure

  2. Need for supplemental medical therapy

  3. Incidence of short and long term surgical complications and need for re-operation.

  4. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Asia Primary Tube Versus Trab (TVT) Study
Actual Study Start Date :
Sep 28, 2016
Anticipated Primary Completion Date :
Oct 30, 2020
Anticipated Study Completion Date :
Oct 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tube implant

Ahmed Glaucoma Implant (AGI) surgery

Device: Ahmed Glaucoma Implant
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

Active Comparator: Trabeculectomy

Trabeculectomy with mitomycin C surgery

Procedure: Trabeculectomy with Mitomycin C
Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure

Outcome Measures

Primary Outcome Measures

  1. Failure [6 months]

    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

  1. IOP [60 months]

    Intraocular pressure (mmHg)

  2. Best Corrected Visual Acuity (BCVA) [60 months]

    ETDRS visual acuity chart (logMAR or equivalent)

  3. Supplemental medication [60 months]

    Number of supplemental glaucoma medications used at Month 60

  4. Adverse Events [60 months]

    Number of Adverse Events during the trial

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Singapore Eye Research Institute Singapore Singapore 168751

Sponsors and Collaborators

  • Singapore Eye Research Institute
  • National Medical Research Council (NMRC), Singapore

Investigators

  • Principal Investigator: Ching Lin Ho, Singapore National Eye Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Ho Ching Lin, Research Director, Singapore Eye Research Institute
ClinicalTrials.gov Identifier:
NCT03274024
Other Study ID Numbers:
  • R1293/99/2015
First Posted:
Sep 6, 2017
Last Update Posted:
Sep 6, 2017
Last Verified:
Sep 1, 2017
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 6, 2017