To demonstrate the clinical efficacy and safety profile of canaloplasty utilizing the iTrackTM Advance canaloplasty device performed via an ab-interno surgical technique achieves:1. Enhanced IOP reduction at 12 months due to the techniques ability…
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Effectiveness endpoints:
1. The mean reduction in IOP at 12-months compared to baseline in the test
group is statistically significantly greater than that of the control group
2. The mean reduction in number of glaucoma medications at 12-months compared
to baseline in the test group is statistically significantly greater than that
of the control group
Secondary outcome
Secondary Effectiveness endpoints:
The primary efficacy endpoints will be analysed as secondary endpoints at
24-months as part of the followup analysis at 24-months.
1. % of patients with complete success of the procedure at 12-month, defined
as: Complete success = Postoperative IOP at 12-month <= 18mmHg and the number of
medications is zero, and without any secondary interventions.
2. % of patients with qualified success of the procedure, defined as: Qualified
success = Postoperative IOP at 12-month <= 18mmHg and the number of medications
is > 0, and without any secondary interventions
3. % of patients with complete success of the procedure at 12-month, defined
as: Complete success = Postoperative IOP at 12-month <= 15mmHg and the number of
medications is zero, and without any secondary interventions
4. % of patients with qualified success of the procedure, defined as: Qualified
success = Postoperative IOP at 12-month <= 15mmHg and the number of medications
is > 0, and without any secondary interventions
5. % of patients with greater than 20% reduction in IOP at 12-month follow-up
6. % of patients with IOP less than/equal to 15 mmHg at 12-month follow-up
7. % reduction in mean number of medications as compared to Screening vs
12-month follow-up
8. % of patients medication-free at 12-month follow-up
9. % of patients on one or less medications at 12-month follow-up
10. Quality of life Questionnaire evaluation
All effectiveness endpoints will also be analyzed at the 24- months* time point.
Safety Endpoints:
1. Summary of Complications/Adverse Events at 12-months
2. Best corrected visual acuity (BCVA) at 12-months
3. Endothelial cell count (ECC) at 12-months compared to baseline
4. Visual field progression: change in visual field mean deviation score (dB)
at 12 months compared to baseline
All safety endpoints will also be analyzed at the 24-months time point.
Background summary
Hitherto, the safety and effectiness of the iTrackTM Advance Canaloplasty
device, performed via an ab-interno approach, combined with cataract surgery
has not been established as compared to cataract surgery on its own.
Nevertheless, this procedure could potentially reduce intraocular pressure to a
larger extent, thereby also reducing glaucoma medication use.
Study objective
To demonstrate the clinical efficacy and safety profile of canaloplasty
utilizing the iTrackTM Advance canaloplasty device performed via an ab-interno
surgical technique achieves:
1. Enhanced IOP reduction at 12 months due to the techniques ability to address
all aspects of the outflow system;
2. Reduced medication use at 12 months due to the techniques ability to address
all aspects of the outflow system
3. Minimal surgical and post-operative complications;
4. Reduced endothelial cell loss which is attributed to the tissue-sparing,
atraumatic mechanism
Study design
This is a prospective, multicenter, randomized, single-masked, post-market
clinical trial with follow-up through 12 months
Intervention
Intervention: iTrackTM Advance canaloplasty device (Nova Eye, Inc.) combined
with cataract surgery
Control: cataract surgery
Study burden and risks
Both the cataract surgery and the canaloplasty procedure are performed as per
normal clinical routine. Therefore, the risks associated with the surgical
procedures are unchanged in the study compared to routine clinical care No
additional invasive assessments are performed throughout the study that would
increase the risk to the patients.
The follow-up includes one additional visit compared to routine clinical care,
as well as Quality of Life Questionnaire
Friedrichstrasse 114a
Berlijn 10117
DE
Friedrichstrasse 114a
Berlijn 10117
DE
Listed location countries
Age
Inclusion criteria
a) Male or female subjects, 55 years or older at the time of surgery.
b) Diagnosed with mild to moderate primary open angle glaucoma, i.e., mean
deviation
score must be better than or equal to -12.0 dB, as documented in patient's
medical
record substantiated using fundoscopic exam or OCT, and at least one visual
field
test with the Humphrey automated perimeter using the SITA Standard 24-2 testing
algorithm.
c) The visual field test may be historical (within 3 months prior to Screening
Visit). If
needed, visual field testing may be repeated between the Screening Visit and
the
Surgery Visit.
d) At the Screening Visit, IOP of <= 25 mmHg while on 1-4 ocular hypotensive
medications.
e) Shaffer grade of >= III in all four quadrants.
f) Endothelial cell density >2000 (cells/mm2) (average of 3 measurements).
g) Patients with visually significant cataract.
h) Able and willing to comply with the study procedures and attend all
follow-up visits.
i) Understands and signs the informed consent.
Exclusion criteria
a) Any of the following prior treatments for glaucoma (study eye):
1. Laser Trabeculoplasty
i) Selective Laser Trabeculoplasty (SLT) conducted within 6-months
of
the Screening Visit
ii) Prior Argon Laser Trabeculoplasty
2. Endocyclophotocoagulation (ECP) or Micropulse laser
3. iStent or iStent Inject
4. Hydrus Microstent
5. Trabeculectomy or other bleb forming procedure including Xen,
Express, and glaucoma
drainage device/valve.
6. Prior canaloplasty (ab-interno and ab-externo)
7. Prior goniotomy, or trabeculotomy (ab-externo and ab-interno)
8. Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN)
9. Concurrent IOP-lowering procedure other than use of the iTrackTM
Advance canaloplasty
device at the time of surgery (e.g., ECP, CPC, etc.)
10. Previous treatment with iTrackTM (Note: permitted if fellow eye only
was treated)
b) Acute angle closure, traumatic, congenital, malignant, uveitic or
neovascular
glaucoma.
c) Eyes with complications related to cataract extraction or IOL implantation
will be
removed from the study.
d) Use of systemic medications (either current, within 30 calendar days of
Screening
exam, or anticipated) that may cause an increase in IOP, (e.g., systemic
steroids including
inhaled and oral steroids used on a regular basis)
e) Ocular diseases (such as corneal endothelial dystrophy, intraocular
inflammation and
infection) that could affect the corneal endothelium; and systemic diseases
(such as
congenital abnormalities) that could affect the corneal endothelium.
f) No other clinically significant concurrent intraocular pathology other than
glaucoma and
cataract at the time of surgery.
g) History of penetrating keratoplasty or another corneal transplant
h) BCVA of 20/200 or worse in the fellow eye not due to cataract.
i) Participation (<= 30 days prior to Screening) in an interventional trial
which could have a
potential effect on the study outcome, as determined by the study Investigator
j) Women of childbearing potential if they are currently pregnant or intend to
become
pregnant during the study period; are breast-feeding; or are not in agreement
to use
adequate birth control methods to prevent pregnancy throughout the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05786196 |
| CCMO | NL86827.068.24 |