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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03106181




Registration number
NCT03106181
Ethics application status
Date submitted
4/04/2017
Date registered
10/04/2017
Date last updated
30/01/2020

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 - Intraocular pressure reduction
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Glaucoma medications - Number of glaucoma medications
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Treatment satisfaction - Patient treatment satisfaction
Timepoint [2] 0 0
12 months

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Other
Name
Center for Eye Research Australia
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
Royal Victoria Eye and Ear Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Glaucoma is the commonest cause of irreversible blindness in the world. Treatment centres
around lowering intraocular pressure (IOP) and typically includes medication (least
invasive), laser, to surgery (most invasive). The gold-standard glaucoma operation is the
trabeculectomy. Whilst it is effective at lowering IOP, it is associated with potentially
devastating complications including bleb leak, hypotonous maculopathy, blebitis and
endophthalmitis. In recent years, minimally- invasive glaucoma surgery (MIGS) has become an
increasingly popular option of treating mild to moderate glaucoma. It is usually performed in
conjunction with cataract surgery. The iStent (Glaukos Corporation, California, USA) is one
of the most commonly utilised MIGS devices in the world and one of two Therapeutic Goods
Administration (TGA)- approved MIGS devices in Australia. The iStent Inject® is the second
generation iStent device and Australia is one of the first countries in the world to have
access to this. So far there are no published randomised controlled trials comparing the
effect of cataract surgery alone to combined cataract surgery with insertion of iStent
Inject®.

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/show/NCT03106181
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer C Fan Gaskin, FRANZCO
Address 0 0
Country 0 0
Phone 0 0
+61399298666
Fax 0 0
Email 0 0
drjfan@gmail.com
Contact person for scientific queries

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