Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Randomised Controlled Trial of Cataract Surgery Versus Combined Cataract Surgery With Insertion of iStent Inject®
Secondary ID [1] 0 0
iStent RCT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma, Open-Angle 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Intraocular pressure
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Glaucoma medications
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Treatment satisfaction
Timepoint [1] 0 0
Up to 2 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Royal Victoria Eye and Ear Hospital
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Glaukos Corporation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Centre for Eye Research Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03106181
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Fan Gaskin, FRANZCO
Address 0 0
Royal Victoria Eye and Ear Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03106181