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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03106181
Registration number
NCT03106181
Ethics application status
Date submitted
4/04/2017
Date registered
10/04/2017
Date last updated
9/08/2023
Titles & IDs
Public title
A Comparison of Cataract Surgery Alone and Cataract Surgery With iStent
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Scientific title
A Randomised Controlled Trial of Cataract Surgery Versus Combined Cataract Surgery With Insertion of iStent Inject®
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Secondary ID [1]
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iStent RCT
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glaucoma, Open-Angle
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - iStent inject®
Treatment: Surgery - Phacoemulsification and intraocular lens implant
Active Comparator: Cataract surgery - Conventional phacoemulsification cataract surgery and intraocular lens implantation
Experimental: Cataract surgery plus iStent inject® - Conventional phacoemulsification cataract surgery and lens implantation plus insertion of iStent inject®
Treatment: Devices: iStent inject®
Insertion of iStent inject®
Treatment: Surgery: Phacoemulsification and intraocular lens implant
Conventional phacoemulsification cataract surgery and intraocular lens implant
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Intraocular pressure
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Assessment method [1]
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Intraocular pressure reduction
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Timepoint [1]
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Up to 2 years
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Primary outcome [2]
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Glaucoma medications
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Assessment method [2]
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Number of glaucoma medications
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Timepoint [2]
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Up to 2 years
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Secondary outcome [1]
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Treatment satisfaction
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Assessment method [1]
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Patient treatment satisfaction
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Timepoint [1]
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Up to 2 years
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Eligibility
Key inclusion criteria
- >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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2022
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Sample size
Target
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Accrual to date
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Final
93
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Victorian Eye and Ear Hospital - East Melbourne
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Royal Victoria Eye and Ear Hospital
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Glaukos Corporation
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Centre for Eye Research Australia
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03106181
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jennifer Fan Gaskin, FRANZCO
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Address
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Royal Victoria Eye and Ear Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03106181
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