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Trial registered on ANZCTR


Registration number
ACTRN12615000892516
Ethics application status
Not yet submitted
Date submitted
7/08/2015
Date registered
26/08/2015
Date last updated
26/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Clinical Investigation of the ClarVista HARMONI(Trademark) Modular Intraocular Lens Implant during Cataract Surgery
Scientific title
A Prospective, Multi-Center, Feasibility Trial of the ClarVista HARMONI (Trademark) Modular Intraocular Lens System for the treatment of Aphakia following Cataract Surgery
Secondary ID [1] 287238 0
none
Universal Trial Number (UTN)
U1111-1172-9889
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 295844 0
Aphakia following cataract surgery 295956 0
Condition category
Condition code
Eye 296098 296098 0 0
Diseases / disorders of the eye
Surgery 296229 296229 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The surgery involves the implantation of an artificial lens inside the eye that replaces the focusing power of the natural lens that has surgically removed as part of cataract surgery. The study device (HARMONI MODULAR Intraocular Lens Implant System) includes a base component and an optic component which allows optic exchange after the primary surgical procedure. A standard implant is a single piece (no components).
This implantation of the study device occurs in one eye while the other eye receives a commercially available artificial lens. The primary implantation procedure takes about 5 minutes but the entire cataract procedure takes about 30 minutes, typically performed under topical or local anesthesia by an ophthalmic surgeon. An optic exchange may be performed 3 months after the primary surgery to adjust the subject's visual function. This procedure takes about 15 minutes under the same anesthetic method and also performed by an ophthalmic surgeon. The implant package label will be collected on the CRF.
Intervention code [1] 292523 0
Treatment: Devices
Comparator / control treatment
Any commercially available clear intraocular lens that is used as standard of care by the investigator.
Control group
Active

Outcomes
Primary outcome [1] 295771 0
Corneal endothelial cell count as measured by specular microscopy of the eye.
Timepoint [1] 295771 0
3 months after an optic exchange procedure has been performed.
Secondary outcome [1] 316484 0
Corneal endothelial cell count as measured by specular microscopy of the eye.
Timepoint [1] 316484 0
3,6,12 months after the primary surgical procedure.
Secondary outcome [2] 316485 0
best corrected distance visual acuity as assessed using and ETDRS chart.
Timepoint [2] 316485 0
3,6,12 months after the primary surgical procedure.
Secondary outcome [3] 316486 0
uncorrected distance visual acuity as assessed using and ETDRS chart.
Timepoint [3] 316486 0
3,6,12 months after the primary surgical procedure.
Secondary outcome [4] 316487 0
manifest refraction spherical equivalent as assessed using a phoropter and an ETDRS chart.
Timepoint [4] 316487 0
3,6,12 months after the primary surgical procedure.

Eligibility
Key inclusion criteria
bilateral cataract, candidate for cataract surgery
Minimum age
22 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
eye or systemic diseases that can influence study outcomes

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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
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)
Safety/efficacy
Statistical methods / analysis
The sample size of this feasibility study is first calculated based on ISO 11979-7:2014. The HMIOL offers the optic component exchange. Another objective of this feasibility study is to assess the safety of the HMIOL optic exchange procedure with respect to its potential impact on the corneal endothelium. The required sample size is 44 HMIOL-exchange eyes with available ECC data at pre-exchange and 3 months post-exchange.  Based on literature review, the expected rate of non-optimal refractive outcome is expected to be up to 50% of subjects enrolled.  Therefore, a sample size of 100 to 200 HMIOL-implanted eyes will have enough statistical power for the ECC hypotheses.

Descriptive statistical analyses will be performed.

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 7083 0
New Zealand
State/province [1] 7083 0
Auckland

Funding & Sponsors
Funding source category [1] 291806 0
Commercial sector/Industry
Name [1] 291806 0
ClarVista Medical
Address [1] 291806 0
26800 Aliso Viejo Parkway, Suite 120
Aliso Viejo, CA 92656
USA
Country [1] 291806 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
ClarVista Medical
Address
26800 Aliso Viejo Parkway, Suite 120
Aliso Viejo, CA 92656
USA
Country
United States of America
Secondary sponsor category [1] 290465 0
None
Name [1] 290465 0
Address [1] 290465 0
Country [1] 290465 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293323 0
Health and Disability Ethics Committee
Ethics committee address [1] 293323 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293323 0
New Zealand
Date submitted for ethics approval [1] 293323 0
13/08/2015
Approval date [1] 293323 0
Ethics approval number [1] 293323 0

Summary
Brief summary
The HARMONI(Trademark) Modular Intraocular Lens Implant System is an implantable artificial lens used to replace the natural lens that has been surgically removed as part of cataract surgery. The study lens is unlike a standard lens which is a single piece. The study lens has a base component and an optic component. The removable optic component allows optic exchange after the primary surgery to adjust the patient's visual function.
The purpose of this study is to demonstrate the feasibility of HARMONI(Trademark) IOL (HMIOL) implantation and assembly in subjects undergoing cataract surgery. It also aims to demonstrate the feasibility of the HMIOL optic component exchange procedure (performed 3 months following primary cataract extraction)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59386 0
Dr Dean Corbett
Address 59386 0
Auckland Eye
8 St Marks Road
Remuera P O Box 99311
Newmarket Auckland 1050
New Zealand
Country 59386 0
New Zealand
Phone 59386 0
+64 9 529 2480
Fax 59386 0
Email 59386 0
dlcorbett@xtra.co.nz
Contact person for public queries
Name 59387 0
Dr May Mendoza
Address 59387 0
Auckland Eye
8 St Marks Road
Remuera P O Box 99311
Newmarket Auckland 1050
New Zealand
Country 59387 0
New Zealand
Phone 59387 0
+64 9 529 2480
Fax 59387 0
Email 59387 0
may@aucklandeye.co.nz
Contact person for scientific queries
Name 59388 0
Dr Dean Corbett
Address 59388 0
Auckland Eye
8 St Marks Road
Remuera P O Box 99311
Newmarket Auckland 1050
New Zealand
Country 59388 0
New Zealand
Phone 59388 0
+64 9 529 2480
Fax 59388 0
Email 59388 0
dlcorbett@xtra.co.nz

No information has been provided regarding IPD availability
Summary results
No Results