NCT02088528

Brief Summary

Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of medications, disease severity and poor compliance. Surgical treatment is likely to be a more practical solution. The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical study.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
298

participants targeted

Target at 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

March 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

7 years

First QC Date

March 11, 2014

Last Update Submit

March 14, 2014

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change in intraocular pressure

    3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years

Secondary Outcomes (6)

  • Complication rates

    1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years

  • Visual acuity

    1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years

  • Visual field

    6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  • Reoperation for glaucoma

    1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years

  • Supplemental medical therapy

    1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years

  • +1 more secondary outcomes

Other Outcomes (1)

  • Patient satisfaction with communications by text message

    1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Study Arms (2)

Aurolab glaucoma drainage device

ACTIVE COMPARATOR
Device: Aurolab glaucoma drainage device

Trabeculectomy with mitomycin-c

ACTIVE COMPARATOR
Procedure: Trabeculectomy with mitomycin-c

Interventions

Aurolab glaucoma drainage deviceDEVICE

Patients undergoing surgery will receive an implant

Also known as: AADI
Aurolab glaucoma drainage device
Trabeculectomy with mitomycin-cPROCEDURE

Trabeculectomy surgery augmented by application of mitomycin C (0.4 mg/ml) to the sclera in the region of the trabeculectomy site for a period of exactly 3 minutes.

Trabeculectomy with mitomycin-c

Eligibility Criteria

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

You may qualify if:

  • Age 18 to 85 years, inclusive
  • Open angle glaucoma. Including primary open angle glaucoma, pseudoexfoliative and pigmentary glaucoma
  • Intraocular pressure 18 - 40 mmHg on maximal tolerated or maximal affordable medical therapy
  • 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
  • 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
  • Steroid-induced glaucoma
  • Severe posterior blepharitis
  • Unwilling to discontinue contact lens use after surgery
  • Previous cyclodestructive procedure
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tema Christian Eye Center

Tema, Ghana

RECRUITING

Related Links

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

  • Alexander Spratt, MBBCh FRCOphth

    Tema Christian Eye Center

    PRINCIPAL INVESTIGATOR

  • Keith Barton, MBBCh MD FRCP FRCOphth

    Moorfields Eye Hospital NHS Foundation Trust

    STUDY CHAIR

  • Donald L Budenz, MD MPH

    University of North Carolina, Chapel Hill

    STUDY CHAIR

Central Study Contacts

Alexander Spratt, MBBCh FRCOphth

CONTACT

+233549446981mail@gptvt.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 17, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2021

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

GH(1)