The Asia Primary Tube Versus Trab (TVT) Study

Glaucoma Clinical Trial

— TVT  

Official title:

The Asia Primary Tube Versus Trab (TVT) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03274024
• Other study ID #: R1293/99/2015
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2017
• Last updated: September 5, 2017
• Start date: September 28, 2016
• Est. completion date: October 30, 2020

Study information

• Verified date: September 2017
• Source: Singapore Eye Research Institute
• Contact: Natalia Porporato, Fellow
• Phone: +6591378217
• Email: natalia.porporato[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

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

Locations

Country	Name	City	State
Singapore	Singapore Eye Research Institute	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore Eye Research Institute	National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	IOP	Intraocular pressure (mmHg)	60 months
Secondary	Best Corrected Visual Acuity (BCVA)	ETDRS visual acuity chart (logMAR or equivalent)	60 months
Secondary	Supplemental medication	Number of supplemental glaucoma medications used at Month 60	60 months
Secondary	Adverse Events	Number of Adverse Events during the trial	60 months