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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03316885
Ethics application status
Date submitted
18/10/2017
Date registered
20/10/2017
Date last updated
21/08/2023

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
Aphakia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

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

Experimental: Clareon IOL - Clareon® aspheric hydrophobic acrylic intraocular lens implanted with the Alcon Monarch III-D delivery system 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.

Treatment: Surgery: Cataract Surgery
Routine small incision cataract surgery with unilateral IOL implantation
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation
Timepoint [1] 0 0
Year 1 post-implantation from second eye surgery
Primary outcome [2] 0 0
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation
Timepoint [2] 0 0
Year 1 post-implantation from second eye surgery
Secondary outcome [1] 0 0
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
Timepoint [1] 0 0
Year 2 post-implantation from second eye surgery
Secondary outcome [2] 0 0
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
Timepoint [2] 0 0
Year 2 post-implantation from second eye surgery
Secondary outcome [3] 0 0
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
Timepoint [3] 0 0
Year 3 post-implantation from second eye surgery
Secondary outcome [4] 0 0
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
Timepoint [4] 0 0
Year 3 post-implantation from second eye surgery
Secondary outcome [5] 0 0
Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye
Timepoint [5] 0 0
Year 1 post-implantation from second eye surgery
Secondary outcome [6] 0 0
UCDVA at 1 Year Post-Implantation - Second Implanted Eye
Timepoint [6] 0 0
Year 1 post-implantation from second eye surgery
Secondary outcome [7] 0 0
UCDVA at 2 Years Post-Implantation - First Implanted Eye
Timepoint [7] 0 0
Year 2 post-implantation from second eye surgery
Secondary outcome [8] 0 0
UCDVA at 2 Years Post-Implantation - Second Implanted Eye
Timepoint [8] 0 0
Year 2 post-implantation from second eye surgery
Secondary outcome [9] 0 0
UCDVA at 3 Years Post-Implantation - First Implanted Eye
Timepoint [9] 0 0
Year 3 post-implantation from second eye surgery
Secondary outcome [10] 0 0
UCDVA at 3 Years Post-Implantation - Second Implanted Eye
Timepoint [10] 0 0
Year 3 post-implantation from second eye surgery

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
Sex
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
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/09/2021
Sample size
Target
Accrual to date
Final
245
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 evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.
Trial website
https://clinicaltrials.gov/study/NCT03316885
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sr. Clinical Trial Lead, CDMA, Surgical
Address 0 0
Alcon Research, LLC
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03316885