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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03274024 |
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Date of registration:
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29/08/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Asia Primary Tube Versus Trab (TVT) Study
TVT |
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Scientific title:
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The Asia Primary Tube Versus Trab (TVT) Study |
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Date of first enrolment:
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September 28, 2016 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03274024 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Serena Ting |
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Address:
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Telephone:
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(+65) 8113 5026 |
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Email:
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serena.ting.m.l@seri.com.sg |
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Affiliation:
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Name:
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Natalia Porporato, Fellow |
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Address:
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Telephone:
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+6591378217 |
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Email:
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natalia.porporato@gmail.com |
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Affiliation:
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Name:
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Ching Lin Ho |
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Address:
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Telephone:
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Email:
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Affiliation:
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Singapore National Eye Centre |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Glaucoma
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Intervention(s)
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Device: Ahmed Glaucoma Implant
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Procedure: Trabeculectomy with Mitomycin C
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Primary Outcome(s)
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Failure
[Time Frame: 6 months]
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Secondary Outcome(s)
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Supplemental medication
[Time Frame: 60 months]
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Best Corrected Visual Acuity (BCVA)
[Time Frame: 60 months]
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Adverse Events
[Time Frame: 60 months]
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IOP
[Time Frame: 60 months]
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Secondary ID(s)
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R1293/99/2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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