Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000692437p
Ethics application status
Submitted, not yet approved
Date submitted
29/03/2025
Date registered
1/07/2025
Date last updated
1/07/2025
Date data sharing statement initially provided
1/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of iStent infinite on glaucoma and dry eye disease
Scientific title
Evaluating the effect of iStent infinite on glaucoma and dry eye disease in ocular hypertension (OHT) and open angle glaucoma (OAG) patients with premium intraocular lenses
Secondary ID [1] 314079 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 336846 0
Dry Eye 336847 0
Condition category
Condition code
Eye 333324 333324 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
iStent infinite and dry eye reduction in ocular hypertension (OHT) and open angle glaucoma (OAG) patients with premium intraocular lenses (IOL)

Participants are adult patients with OHT or mild-to-moderate (greater than or equal to 12 dB) controlled OAG and topical glaucoma medication-associated dry eyes planned for cataract surgery or who have had prior premium IOL implantation who are willing to be followed up to 24 months postoperative and the following inclusion criteria pertaining to dry eye:

1. Cataract surgery alone (20mins by ophthalmologist)
Standard phacoemulsification will be performed through a temporal clear corneal incision, and a foldable intraocular lens implanted in the posterior capsule of all eyes. Under topical or sub-Tenon's anaesthesia dependent on patient preference.


2. iStent infinite alone (10mins by ophthalmologist)
Pre-op pupil constriction with Pilocarpine 2% x3 instillations
iStent infinite implantation will consist of these steps: through a single temporal peripheral clear corneal incision, after filling the anterior chamber with viscoelastic, the iStent infinite injector will be advanced under direct gonioscopy to the nasal trabecular meshwork, where the first stent will be implanted through the meshwork into Schlemm’s canal.
The injector tip will be repositioned to implant the second stent ~2 clock-hours away from the first stent. The third stent will be implanted using the same procedure as the previous stents, placing the implant ~2 clock hours away from either of the first 2 stents.
To ensure optimal positioning and angle of approach, the surgeon may choose to exit the eye and reposition after the first or second stent implant.
After insertion of the 3 stents, proper placement and seating in the trabecular meshwork will be confirmed under intraoperative gonioscopy. [record stents are minimum 2 clock-hours apart]
Viscoelastic will be removed and sealing of the corneal incision will be ensured.

3. iStent infinite combo procedure (30 mins by ophthalmologist)
Stents will be placed at the end of cataract surgery.

Procedural records will be kept to monitor adherence to the intervention
Intervention code [1] 330649 0
Treatment: Devices
Intervention code [2] 330650 0
Treatment: Surgery
Comparator / control treatment
1. Cataract surgery alone
Control group
Active

Outcomes
Primary outcome [1] 340897 0
Change in mean intraocular pressure (IOP)
Timepoint [1] 340897 0
Baseline, Post-operatively Day 1 (POD1), Post-operatively Week 1 (POW1), Post-operatively 1 month (POM1), POM3, POM6, 12, 18 and 24 months
Primary outcome [2] 341000 0
Change in mean medications
Timepoint [2] 341000 0
Baseline, Post-operatively Day 1 (POD1), Post-operatively Week 1 (POW1), Post-operatively 1 month (POM1), POM3, POM6, 12, 18 and 24 months
Primary outcome [3] 341001 0
Change in visual acuity (VA)
Timepoint [3] 341001 0
Baseline, Post-operatively Day 1 (POD1), Post-operatively Week 1 (POW1), Post-operatively 1 month (POM1), POM3, POM6, 12, 18 and 24 months
Secondary outcome [1] 445381 0
Ocular comfort
Timepoint [1] 445381 0
Baseline, Post-operatively Day 1 (POD1), Post-operatively Week 1 (POW1), Post-operatively 1 month (POM1), POM3, POM6, 12, 18 and 24 months
Secondary outcome [2] 445757 0
ocular surface tear film stability
Timepoint [2] 445757 0
Baseline, Post-operatively Day 1 (POD1), Post-operatively Week 1 (POW1), Post-operatively 1 month (POM1), POM3, POM6, 12, 18 and 24 months

Eligibility
Key inclusion criteria
Adult patients with OHT or mild-to-moderate (greater than or equal to 12 dB) controlled OAG and topical glaucoma medication-associated dry eyes planned for cataract surgery or who have had prior premium intraocular lens (IOL) implantation who are willing to be followed up to 24 months postoperatively
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
: History of incisional glaucoma surgery, argon laser trabeculoplasty, iridectomy, or iridotomy, or completion of selective laser trabeculoplasty within 90 days before screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Within group (standalone, combo, control)
Between groups (combo vs. control)
• Report 95% confidence intervals
• Descriptive stats for parametric continuous measurements will be mean ± standard deviation and median (interquartile range) for nonparametric measurements
• Two-sample t-test to compare means between groups
• Chi-squared test to compare counts/proportions between groups
• Multilevel mixed-effects regression modelling for longitudinal follow-ups of continuous, count, and binomial variables controlled for preop IOP, preop med
• Kaplan Meier curve to measure cumulative success and Cox proportional hazard regression to compare treatment groups and account for confounding variables
• Scatterplot of preop vs. postop IOP
• Line plot of observed data (e.g., mean IOP of all eyes with data at a specific timepoint)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2027
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318588 0
Commercial sector/Industry
Name [1] 318588 0
Glaukos Corporation
Country [1] 318588 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Glaukos Corporation
Address
Country
United States of America
Secondary sponsor category [1] 320985 0
None
Name [1] 320985 0
Address [1] 320985 0
Country [1] 320985 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317186 0
The Royal Australian and New Zealand College of Ophthalmologists (RANZCO) Human Research Ethics Committee
Ethics committee address [1] 317186 0
Ethics committee country [1] 317186 0
Australia
Date submitted for ethics approval [1] 317186 0
29/03/2025
Approval date [1] 317186 0
Ethics approval number [1] 317186 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140282 0
Dr Kenneth Gek-Jin Ooi
Address 140282 0
Sydney Eye Clinic, 213 Darlinghurst Rd, Darlinghurst, NSW 2010
Country 140282 0
Australia
Phone 140282 0
+61 411690672
Fax 140282 0
Email 140282 0
[email protected]
Contact person for public queries
Name 140283 0
Kenneth Gek-Jin Ooi
Address 140283 0
Sydney Eye Clinic, 213 Darlinghurst Rd, Darlinghurst, NSW 2010
Country 140283 0
Australia
Phone 140283 0
+61 411690672
Fax 140283 0
Email 140283 0
[email protected]
Contact person for scientific queries
Name 140284 0
Kenneth Gek-Jin Ooi
Address 140284 0
Sydney Eye Clinic, 213 Darlinghurst Rd, Darlinghurst, NSW 2010
Country 140284 0
Australia
Phone 140284 0
+61 411690672
Fax 140284 0
Email 140284 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.