NCT03274024

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

4.1 years

First QC Date

August 29, 2017

Last Update Submit

September 5, 2017

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • IOP

    60 months

  • Best Corrected Visual Acuity (BCVA)

    60 months

  • Supplemental medication

    60 months

  • Adverse Events

    60 months

Study Arms (2)

Tube implant

EXPERIMENTAL

Ahmed Glaucoma Implant (AGI) surgery

Device: Ahmed Glaucoma Implant

Trabeculectomy

ACTIVE COMPARATOR

Trabeculectomy with mitomycin C surgery

Procedure: Trabeculectomy with Mitomycin C

Interventions

Ahmed Glaucoma ImplantDEVICE

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

Tube implant
Trabeculectomy with Mitomycin CPROCEDURE

Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure

Trabeculectomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Eye Research Institute

Singapore, 168751, Singapore

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

TrabeculectomyMitomycin

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, OperativeMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ching Lin Ho

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Porporato, Fellow

CONTACT

+6591378217natalia.porporato@gmail.com

Ya Ying Ooi

CONTACT

+658186 7051ooi.ya.ying@seri.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 6, 2017

Study Start

September 28, 2016

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

SG(1)