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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03316885




Registration number
NCT03316885
Ethics application status
Date submitted
18/10/2017
Date registered
18/10/2017
Date last updated
11/09/2018

Titles & IDs
Public title
Post-Market Clinical Investigation of the Clareon® IOL
Scientific title
Post-Market Clinical Investigation of the Clareon® IOL
Secondary ID [1] 0 0
ILJ466-P003
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Clareon® IOL

Experimental: Clareon IOL - Clareon® aspheric hydrophobic acrylic intraocular lens implanted as a replacement of the human crystalline lens during cataract surgery


Treatment: Devices: Clareon® IOL
Foldable, single-piece posterior chamber IOL intended for long-term use over the lifetime of the cataract patient. This device is CE-marked (European Conformity) in the countries with participating Investigators.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of subjects achieving best-corrected distance visual acuity (BCDVA) of 0.3 logarithm minimum angle of resolution (logMAR) or better at 3 years post-implantation - Visual acuity (VA) will be tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA will be measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart, and compared to the historical safety and performance endpoint (SPE) of 92.5% (EN ISO 11979-7:2014).
Timepoint [1] 0 0
Year 3 (second eye)
Secondary outcome [1] 0 0
Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 1 year post-implantation - A lower numeric value will represent better visual acuity.
Timepoint [1] 0 0
Year 1 (second eye)
Secondary outcome [2] 0 0
Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 2 years post-implantation
Timepoint [2] 0 0
Year 2 (second eye)
Secondary outcome [3] 0 0
Uncorrected distance visual acuity (UCDVA) at 1 year post-implantation - VA will be tested monocularly under photopic conditions without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power will be applied to correct for optical infinity. VA will be measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart, A lower numeric value will represent better visual acuity.
Timepoint [3] 0 0
Year 1 (second eye)
Secondary outcome [4] 0 0
UCDVA at 2 years post-implantation
Timepoint [4] 0 0
Year 2 (second eye)
Secondary outcome [5] 0 0
UCDVA at 3 years post-implantation
Timepoint [5] 0 0
Year 3 (second eye)

Eligibility
Key inclusion criteria
Key

- Diagnosed with bilateral cataracts

- Planned small incision cataract removal surgery

- Able to comprehend and willing to sign a statement of informed consent and complete
all required post-implantation visits

Key
Minimum age
22 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who may reasonably be expected to require ocular surgical treatment or
refractive surgical procedures at any time during the study

- Certain eye conditions, as specified in the protocol, including but not limited to
glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration

- Pregnant or lactating, current or planned during the course of the study

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alcon Investigative Site - Footscray
Recruitment hospital [2] 0 0
Alcon Investigative Site - Mornington
Recruitment hospital [3] 0 0
Alcon Investigative Site - Sydney
Recruitment postcode(s) [1] 0 0
3011 - Footscray
Recruitment postcode(s) [2] 0 0
3931 - Mornington
Recruitment postcode(s) [3] 0 0
2067 - Sydney
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Cedex
Country [2] 0 0
France
State/province [2] 0 0
Lyon
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
Germany
State/province [4] 0 0
Frankfurt
Country [5] 0 0
Germany
State/province [5] 0 0
Heidelberg
Country [6] 0 0
Italy
State/province [6] 0 0
Perugia
Country [7] 0 0
Italy
State/province [7] 0 0
Pisa
Country [8] 0 0
Netherlands
State/province [8] 0 0
Amsterdam
Country [9] 0 0
Spain
State/province [9] 0 0
Cadiz
Country [10] 0 0
Spain
State/province [10] 0 0
Alcalá De Henares
Country [11] 0 0
Spain
State/province [11] 0 0
Oviedo
Country [12] 0 0
Spain
State/province [12] 0 0
San Sebastián
Country [13] 0 0
Spain
State/province [13] 0 0
Valencia
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Carshalton
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Brighton
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alcon Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to demonstrate the long-term (3 years) favorable visual
acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL) compared to
historical safety and performance endpoint (SPE) rates as reported in EN ISO 11979-7:2014.
The secondary purpose of this study is to evaluate the refractive outcomes obtained with up
to 3 years follow-up in eyes implanted with the Clareon® IOL.
Trial website
https://clinicaltrials.gov/show/NCT03316885
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alcon, a Novartis Division
Address 0 0
Alcon, a Novartis Division
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications