Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001076460
Ethics application status
Approved
Date submitted
4/09/2025
Date registered
2/10/2025
Date last updated
2/10/2025
Date data sharing statement initially provided
2/10/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using non-contact imaging to compare the positioning of different stents in glaucoma patients
Scientific title
Utilising Anterior Segment Optical Coherence Tomography (OCT) to Compare the Position and Location of the Hydrus Microstent and iStent Infinite in Glaucoma Patients
Secondary ID [1] 315302 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 338772 0
Condition category
Condition code
Eye 335067 335067 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the positioning of the Hydrus Microstent and iStent Infinite devices after insertion into the eye of patients undergoing routine glaucoma surgery.

The iStent Infinite consists of three tiny metal stents, each less than 1mm long which are inserted into the eye's natural drainage pathway to bypass blockages and allow fluid to drain more freely. The Hydrus Microstent is an eyelash-sized, U-shaped flexible scaffold implanted in the eye's natural drainage canal to provide a larger pathway for fluid to drain.
The stents will be inserted by an ophthalmologist, and the surgery will take approximately 30 minutes.

The device used will be randomly allocated based on a predefined randomisation schedule. The positioning of the devices will be examined 3 months post insertion using a specialized camera which takes high resolution images of the eye. This imaging is performed as standard for patients undergoing glaucoma surgery.

The camera is a non-invasive device that contains a chin rest where you place your head to keep still while you look into a light source inside the machine. The images will be taken by an orthoptist and will take up to 15 minutes to complete.
Intervention code [1] 331906 0
Treatment: Devices
Comparator / control treatment
iStent Infinite. This device consists of three tiny metal stents which will be surgically implanted into the eye's natural drainage pathway.
The stent will be inserted by an ophthalmologist, and the surgery will take approximately 30 minutes.
The positioning of the devices will be examined 3 months post insertion using a specialized camera which takes high resolution images of the eye.
Control group
Active

Outcomes
Primary outcome [1] 342699 0
The proportion of stents correctly positioned in the trabecular meshwork (TM) and Schlemm’s canal (SC).
Timepoint [1] 342699 0
Assessed at 3 months post surgery.
Secondary outcome [1] 451861 0
Proportion of individual stents whose positioning in the TM and SC remains the same between Week 1, and Month 3 post-surgery
Timepoint [1] 451861 0
Assessed Week 1 and 3 months post-surgery
Secondary outcome [2] 451862 0
Diameter and cross-sectional area of SC. This will be assessed as a composite outcome
Timepoint [2] 451862 0
Assessed 3 months post-surgery
Secondary outcome [3] 451863 0
Mean change in intraocular pressure (mmHg) from preoperative baseline to 3 months post-surgery
Timepoint [3] 451863 0
Assessed pre-operative, Day 1 post, Week 1 post and Month 3 post-surgery
Secondary outcome [4] 451864 0
Mean change in topical hypotensive medication from baseline to 3 months post-surgery
Timepoint [4] 451864 0
Assessed pre-operative and 3 months post-surgery

Eligibility
Key inclusion criteria
• Age older than 18 years
• Visually significant age-related cataract
• Mild or moderate primary open angle glaucoma severity (as per Hodapp-Anderson-Parrish grading scale based on preoperative visual field mean deviation)
• Open angle on gonioscopy: grade 3 or 4 according to Shaffer Angle Grading System
• Cup-to-Disc (C:D) ratio equal to or less than 0.8
• Visual field defects with mean deviation ranging from 0 dB to -12dB (inclusive)
• Pre-operative medicated or unmedicated IOP equal to or greater than 7 mmHg and equal to or less than 29 mmHg.
• Current treatment with 0 to 4 ocular hypotensive medications
• Planning to undergo trabecular micro-bypass with Hydrus microstent or three iStent
inject W stents, in combination with phaco-emulsification cataract surgery
• No previous ocular surgery
• No other ocular disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Those with poor quality AS-OCT images
• Patients with angle closure glaucoma and/or those with angle abnormalities
• Patients with secondary glaucoma including traumatic, malignant, uveitic, neovascular
• Prior glaucoma surgery
• Selective Laser Trabeculoplasty within 3 months from date of surgery
• Plan for future ocular surgery or retinal laser
• Visual field defect in 10 degrees of central field
• History of intraocular surgery or inflammation
• Difference of greater than 0.5mm between the two eyes in ocular biometry parameters
pertaining to anterior chamber depth

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/09/2025
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 28415 0
Lions Eye Institute Day Surgery Centre - Nedlands
Recruitment postcode(s) [1] 44643 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 319876 0
Commercial sector/Industry
Name [1] 319876 0
Alcon Science
Country [1] 319876 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Lions Eye Institute
Address
Country
Australia
Secondary sponsor category [1] 322404 0
None
Name [1] 322404 0
Address [1] 322404 0
Country [1] 322404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318428 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 318428 0
Ethics committee country [1] 318428 0
Australia
Date submitted for ethics approval [1] 318428 0
21/07/2025
Approval date [1] 318428 0
25/08/2025
Ethics approval number [1] 318428 0

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

Contacts
Principal investigator
Name 144158 0
Dr Geoffrey Chan
Address 144158 0
Lions Eye Institute 2 Verdun St, Nedlands WA 6009
Country 144158 0
Australia
Phone 144158 0
+61 8 9381 0626
Fax 144158 0
Email 144158 0
[email protected]
Contact person for public queries
Name 144159 0
Geoffrey Chan
Address 144159 0
Lions Eye Institute, 2 Verdun St, Nedlands WA 6009
Country 144159 0
Australia
Phone 144159 0
+61 8 9381 0626
Fax 144159 0
Email 144159 0
[email protected]
Contact person for scientific queries
Name 144160 0
Geoffrey Chan
Address 144160 0
Lions Eye Institute, 2 Verdun St, Nedlands WA 6009
Country 144160 0
Australia
Phone 144160 0
+61 8 9381 0626
Fax 144160 0
Email 144160 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data is not planned to be shared to maintain patient privacy. The results of this study will be made publicly available at the completion of the study



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.