Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000579897p
Ethics application status
Submitted, not yet approved
Date submitted
20/01/2021
Date registered
17/05/2021
Date last updated
17/05/2021
Date data sharing statement initially provided
17/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Efficacy and Safety of Three iStent Inject W Implants With or Without Cataract Surgery For Patients With Glaucoma
Scientific title
The effect of three trabecular micro-bypass stents (iStent inject W), with or without phacoemulsification, on intraocular pressure in patients with open-angle glaucoma
Secondary ID [1] 303225 0
None
Universal Trial Number (UTN)
U1111-1264-0402
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary or Secondary Open-angle Glaucoma 320376 0
Condition category
Condition code
Eye 318276 318276 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
24
Target follow-up type
Months
Description of intervention(s) / exposure
Insertion of 3 trabecular bypass stents (iStent inject W) with or without cataract surgery.
1. Receipt of treatment is not conditional on participation in the study (patients meeting inclusion/exclusion criteria not wishing to be enrolled in a study are still eligible to receive the described treatment)
2. Follow-up from the date of treatment will be a minimum 24 months with assessments at 3-6 monthly intervals after the initial post-operative phase.
3. Follow-up will require a 1 hour appointment during which primary and secondary outcome measures will be assessed
4. The istent inject W (x3) will be injected into the nasal trabecular meshwork, @ 2 clock-hour intervals, at the time of cataract surgery or as a stand-alone procedure under topical or local anaesthesia in an operating theatre
5. Stents will be inserted by an ophthalmologist experienced in the use of the istent inject device.
6. Confirmation of iStent inject W placement will be recorded in the patients surgical records a copy of which will be retained in the patient records.
7. Patients with visually significant cataract who meet the inclusion/exclusion criteria for istent inject W (x3) will have stent placement combined with cataract surgery. Patients without cataract or who've previously undergone cataract surgery who meet the inclusion/exclusion criteria for istent inject W (x3) will have stent placement as a stand-alone procedure.
Intervention code [1] 320547 0
Not applicable
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326262 0
Intraocular Pressure using Goldman applanation tonometry
Timepoint [1] 326262 0
At enrolment (pre-op baseline) then at the following intervals following surgery : day 1, week 1, month 1, month 3, month 6, month 12, month 18 and month 24. Primary end-points will be reported for 12-month and 24-month data.
Secondary outcome [1] 390804 0
Number of Glaucoma Medications documented in the patient clinical record
Timepoint [1] 390804 0
At enrolment (pre-op baseline) then at the following intervals following surgery : day 1, week 1, month 1, month 3, month 6, month 12, month 18 and month 24.
Secondary outcome [2] 390805 0
Any intervention undertaken to reduce the intra-ocular pressure. This will be obtained from the patient clinical record and may include (but is not limited to) laser trabeculoplasty, insertion of further istent inject W, use of another MIGS device, trabeculectomy or a glaucoma drainage device.
Timepoint [2] 390805 0
At enrolment (pre-op baseline) then at the following intervals following surgery : day 1, week 1, month 1, month 3, month 6, month 12, month 18 and month 24.
Secondary outcome [3] 391898 0
Visual Acuity measured with Snellen acuity charts and documented in the patient clinical record.
Timepoint [3] 391898 0
At enrolment (pre-op baseline) then at the following intervals following surgery : day 1, week 1, month 1, month 3, month 6, month 12, month 18 and month 24.
Secondary outcome [4] 391899 0
Visual Field using Zeiss Humphrey automated perimetry
Timepoint [4] 391899 0
At enrolment (pre-op baseline) then at the following intervals following surgery : month 6, month 12, month 18 and month 24.
Secondary outcome [5] 391900 0
Retinal Nerve Fibre Layer changes measured using optical coherence tomography (OCT)
Timepoint [5] 391900 0
At enrolment (pre-op baseline) then at the following intervals following surgery : month 6, month 12, month 18 and month 24.

Eligibility
Key inclusion criteria
1. Pseudophakic or phakic (with cataract surgery for combined group)
2. Diagnosis of OAG, including primary open-angle glaucoma (POAG), normal-tension glaucoma (NTG), or pseudoexfoliative glaucoma (PXG).
3. Cup-to-Disc (C:D) ratio less than 0.9
4. VF defects with mean deviation ranging from 0 dB to -18dB (inclusive)
5. Mild, moderate, or severe glaucoma severity (per Hodapp-Anderson-Parrish grading scale based on preoperative VF MD)
6. Medicated or unmedicated IOP greater than 7 mmHg and less than 29 mmHg
7. Current treatment with 0 to 4 ocular hypotensive medications
8. Normal angle anatomy as determined by gonioscopy
9. Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stents
10. Planning to undergo or have undergone (within the prior 90 days) trabecular micro-bypass with three iStent inject W stents
11. Able and willing to attend follow-up exams for 12 (or 24) months
12. Able and willing to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Traumatic, uveitic, neovascular, pigmentary, or angle-closure glaucoma; or glaucoma associated with vascular disorders
2. Active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
3. Significant corneal dystrophy (e.g., bullous keratopathy, Fuch’s dystrophy), guttata, or opacities/disorders preventing angle visualization
4. Corneal surgery (prior or anticipated) of any type (e.g., LASIK, LASEK, PRK, PK, etc.) that may interfere with IOP measurement reliability
5. Angle closure or Shaffer grade < 2
6. Congenital or traumatic cataract
7. Retinal or optic nerve disorders not associated with glaucoma
8. Elevated episcleral venous pressure (e.g., thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital congestion)
9. Chronic or acute ocular inflammation (e.g., uveitis, iritis, retinitis)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
No formal sample size calculation was performed. Assuming a 20% drop-out rate per year, approximately 75 patients will be enrolled in this registry to yield at least 60 patients per treatment arm with follow-up data at 2 years post-procedure.

The primary efficacy endpoint is the percentage of eyes with greater than 20% IOP reduction vs preoperative IOP. Mean IOP will be reported at baseline and at each post-treatment follow-up time point and change from baseline to each time point will be calculated for each eye.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 307633 0
Self funded/Unfunded
Name [1] 307633 0
Colin Clement
Country [1] 307633 0
Australia
Primary sponsor type
Individual
Name
Colin Clement
Address
Eye Associates
Level 4, 187 Macquarie Street
Sydney. NSW 2000
Country
Australia
Secondary sponsor category [1] 308317 0
None
Name [1] 308317 0
Address [1] 308317 0
Country [1] 308317 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307675 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 307675 0
123 Glen Osmond Road
Eastwood
South Australia 5063
Ethics committee country [1] 307675 0
Australia
Date submitted for ethics approval [1] 307675 0
22/01/2021
Approval date [1] 307675 0
Ethics approval number [1] 307675 0

Summary
Brief summary
This is a multi-center, prospective, open-label, post-market registry of the safety and efficacy following implantation of iStent inject W stents (G2W), with or without phacoemulsification, in eyes with OAG in a real-world clinical setting. All patients will be evaluated at a preoperative visit the post-operative visita on Day 1, Week 1, and Month 1, 3, 6, 12, 18 and 24 after treatment. Slit lamp and fundus/optic nerve assessments, Gonioscopy, Pachymetry, Visual Field (VF) and Optical Coherence Tomography (OCT) assessment f Retinal nerve fiber layer (RNFL) will be performed at pretreatment baseline and at appropriate times after treatment. it is expected the intervention will demonstrate clinically significant IOP-lowering with a good safety profile.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 108094 0
Dr Colin Clement
Address 108094 0
Eye Associates
Level 4, 187 Macquarie Street
Sydney NSW 2000
Country 108094 0
Australia
Phone 108094 0
+61 2 9247 9972
Fax 108094 0
Email 108094 0
[email protected]
Contact person for public queries
Name 108095 0
Dr Colin Clement
Address 108095 0
Eye Associates
Level 4, 187 Macquarie Street
Sydney NSW 2000
Country 108095 0
Australia
Phone 108095 0
+61 2 9247 9972
Fax 108095 0
Email 108095 0
[email protected]
Contact person for scientific queries
Name 108096 0
Dr Colin Clement
Address 108096 0
Eye Associates
Level 4, 187 Macquarie Street
Sydney NSW 2000
Country 108096 0
Australia
Phone 108096 0
+61 2 9247 9972
Fax 108096 0
Email 108096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.