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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Post-Market Clinical Investigation of the Clareon® IOL
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Secondary ID [1]
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ILJ466-P003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cataract
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Aphakia
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Visual acuity (VA) was tested for the first implanted eye 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 was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical safety and performance endpoint (SPE) of 92.5% [as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014].
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Timepoint [1]
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Year 1 post-implantation from second eye surgery
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Primary outcome [2]
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Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation
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Assessment method [2]
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VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical SPE of 92.5% (EN ISO 11979-7:2014).
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Timepoint [2]
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Year 1 post-implantation from second eye surgery
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Secondary outcome [1]
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Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
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Assessment method [1]
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VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
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Timepoint [1]
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Year 2 post-implantation from second eye surgery
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Secondary outcome [2]
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Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
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Assessment method [2]
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VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
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Timepoint [2]
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Year 2 post-implantation from second eye surgery
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Secondary outcome [3]
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Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
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Assessment method [3]
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VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
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Timepoint [3]
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Year 3 post-implantation from second eye surgery
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Secondary outcome [4]
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Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
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Assessment method [4]
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VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
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Timepoint [4]
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Year 3 post-implantation from second eye surgery
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Secondary outcome [5]
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Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye
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Assessment method [5]
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VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
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Timepoint [5]
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Year 1 post-implantation from second eye surgery
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Secondary outcome [6]
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UCDVA at 1 Year Post-Implantation - Second Implanted Eye
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Assessment method [6]
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VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
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Timepoint [6]
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Year 1 post-implantation from second eye surgery
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Secondary outcome [7]
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UCDVA at 2 Years Post-Implantation - First Implanted Eye
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Assessment method [7]
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VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
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Timepoint [7]
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Year 2 post-implantation from second eye surgery
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Secondary outcome [8]
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UCDVA at 2 Years Post-Implantation - Second Implanted Eye
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Assessment method [8]
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VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
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Timepoint [8]
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Year 2 post-implantation from second eye surgery
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Secondary outcome [9]
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UCDVA at 3 Years Post-Implantation - First Implanted Eye
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Assessment method [9]
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VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
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Timepoint [9]
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Year 3 post-implantation from second eye surgery
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Secondary outcome [10]
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UCDVA at 3 Years Post-Implantation - Second Implanted Eye
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Assessment method [10]
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VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
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Timepoint [10]
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Year 3 post-implantation from second eye surgery
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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
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Minimum age
22
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/09/2021
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Sample size
Target
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Accrual to date
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Final
245
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alcon Investigative Site - Footscray
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Recruitment hospital [2]
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Alcon Investigative Site - Mornington
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Recruitment hospital [3]
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Alcon Investigative Site - Sydney
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Recruitment postcode(s) [1]
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3011 - Footscray
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Recruitment postcode(s) [2]
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3931 - Mornington
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Recruitment postcode(s) [3]
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2067 - Sydney
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Cedex
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Country [2]
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France
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State/province [2]
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Lyon
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Country [3]
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France
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State/province [3]
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Paris
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Country [4]
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Germany
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State/province [4]
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Frankfurt
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Country [5]
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Germany
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State/province [5]
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Heidelberg
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Country [6]
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Italy
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State/province [6]
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Perugia
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Country [7]
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Italy
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State/province [7]
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Pisa
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Country [8]
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Netherlands
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State/province [8]
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Amsterdam
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Country [9]
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Spain
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State/province [9]
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Cadiz
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Country [10]
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Spain
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State/province [10]
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Alcalá De Henares
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Country [11]
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Spain
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State/province [11]
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Oviedo
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Country [12]
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Spain
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State/province [12]
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San Sebastián
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Country [13]
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Spain
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State/province [13]
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Valencia
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Country [14]
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United Kingdom
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State/province [14]
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Carshalton
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Country [15]
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United Kingdom
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State/province [15]
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Brighton
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Country [16]
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United Kingdom
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State/province [16]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Alcon Research
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03316885
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sr. Clinical Trial Lead, CDMA, Surgical
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Address
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Alcon Research, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03316885
Download to PDF