NCT03106181

Brief Summary

This study aims to recruit patients of the Glaucoma Investigative and Research Unit (GIRU) of Royal Victorian Eye and Ear Hospital (RVEEH) with mild to moderate glaucoma who are due to undergo cataract surgery and randomise each to either cataract surgery or combined cataract surgery with iStent Inject® insertion. Only patients who meet the inclusion criteria and none of the exclusion criteria will be recruited. The outcomes measures of the study will be a comparison of: 1) extent of IOP reduction; 2) reduction in number of topical glaucoma medications; 3) patient treatment satisfaction - between the two treatment groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

4.2 years

First QC Date

April 4, 2017

Last Update Submit

August 7, 2023

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (2)

  • Intraocular pressure

    Intraocular pressure reduction

    Up to 2 years

  • Glaucoma medications

    Number of glaucoma medications

    Up to 2 years

Secondary Outcomes (1)

  • Treatment satisfaction

    Up to 2 years

Study Arms (2)

Cataract surgery

ACTIVE COMPARATOR

Conventional phacoemulsification cataract surgery and intraocular lens implantation

Procedure: Phacoemulsification and intraocular lens implant

Cataract surgery plus iStent inject®

EXPERIMENTAL

Conventional phacoemulsification cataract surgery and lens implantation plus insertion of iStent inject®

Device: iStent inject®Procedure: Phacoemulsification and intraocular lens implant

Interventions

iStent inject®DEVICE

Insertion of iStent inject®

Cataract surgery plus iStent inject®
Phacoemulsification and intraocular lens implantPROCEDURE

Conventional phacoemulsification cataract surgery and intraocular lens implant

Cataract surgeryCataract surgery plus iStent inject®

Eligibility Criteria

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

You may qualify if:

  • \>18 years of age
  • Diagnosis of mild-to-moderate open angle glaucoma
  • Presence of cataract requiring surgery
  • Good understanding of both verbal and written English
  • Able to provide informed consent

You may not qualify if:

  • Recent intraocular surgery within last 3 months
  • Other ocular pathology affecting vision
  • Inability to complete the elements of the study, eg: coma, hemodynamic instability, ventilator dependence, that could be of concern in the investigator's judgment.
  • Non-elective hospitalisation within the past 60 days that could be of concern in the investigator's judgment.
  • Medical illness that in the judgment of the investigator would jeopardise the safe completion of the study. Examples include cancer, chronic inflammatory disease, chronic liver insufficiency, epilepsy, thrombocytosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

PhacoemulsificationLens Implantation, Intraocular

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Jennifer Fan Gaskin, FRANZCO

    Royal Victoria Eye and Ear Hospital

    PRINCIPAL INVESTIGATOR

  • Brian Ang, FRANZCO

    Royal Victoria Eye and Ear Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 10, 2017

Study Start

February 1, 2018

Primary Completion

March 31, 2022

Study Completion

December 31, 2022

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)