The Asia Primary Tube versus Trab (TVT) Study

JRCT ID: jRCTs062180070

Registered date:19/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma.
• Date of first enrollment: 18/01/2018
• Target sample size: 10
• Countries of recruitment: Vietnam,Japan,Singapore,Japan,China,Japan,India,Japan,Thailand,Japan,Hongkong,Japan,Indonesia,Japan,Philippines,Japan,Malaysia,Japan,Korea,Japan,SaudiArabia,Japan
• Study type: Interventional
• Intervention(s): Two groups were randomly assigned: tube shunt surgery group or trabeculectomy group.

Outcome(s)

Primary Outcome

Evaluate the change of mean intraocular pressure.

Failure defined by following criteria

IOP 18 mm Hg or more on two consecutive follow-up visits after 6 months.

IOP was not reduced to 20% below baseline on two consecutive visits after 6 months.

IOP 5 mmHg or less 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

IOP at Month 60.

Number of supplemental glaucoma medications used at Month 60.

ETDRS (BCVA) at Month 60.

Number of Adverse Events during the trial.

Number of patients with 3 lines or more loss in ETDRS BCVA at month 60.

Outcomes based on 21mmHg or more to allow comparisons with US-TVT.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

Age 18 to 85 years, inclusive.
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.

Exclude 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 in study eye, 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.

Related Information

• Primary Sponsor: Kiuchi Yoshiaki
• Secondary ID(s): UMIN000031405