Post-Market Clinical Investigation of the Clareon® IOL
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the final visit (990-1140 days post-implantation from the date of second eye surgery).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Clareon IOL Clareon® aspheric hydrophobic acrylic intraocular lens implanted as a replacement of the human crystalline lens during cataract surgery |
Device: 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 [Year 3 (second eye)]
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).
Secondary Outcome Measures
- Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 1 year post-implantation [Year 1 (second eye)]
A lower numeric value will represent better visual acuity.
- Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 2 years post-implantation [Year 2 (second eye)]
- Uncorrected distance visual acuity (UCDVA) at 1 year post-implantation [Year 1 (second eye)]
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.
- UCDVA at 2 years post-implantation [Year 2 (second eye)]
- UCDVA at 3 years post-implantation [Year 3 (second eye)]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Diagnosed with bilateral cataracts
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Planned small incision cataract removal surgery
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Able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits
Key Exclusion Criteria:
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Subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study
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Certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration
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Pregnant or lactating, current or planned during the course of the study
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Alcon Investigative Site | Footscray | Victoria | Australia | 3011 |
2 | Alcon Investigative Site | Mornington | Victoria | Australia | 3931 |
3 | Alcon Investigative Site | Sydney | Australia | 2067 | |
4 | Alcon Investigative Site | Brest | Cedex | France | 29609 |
5 | Alcon Investigative Site | Lyon | France | 69003 | |
6 | Alcon Investigative Site | Paris | France | 75014 | |
7 | Alcon Investigative Site | Frankfurt | Germany | 60590 | |
8 | Alcon Investigative Site | Heidelberg | Germany | 69120 | |
9 | Alcon Investigative Site | Perugia | Italy | 06129 | |
10 | Alcon Investigative Site | Pisa | Italy | 56124 | |
11 | Alcon Investigative Site | Amsterdam | Netherlands | 1105AZ | |
12 | Alcon Investigative Site | Jerez De La Frontera | Cadiz | Spain | 11408 |
13 | Alcon Investigative Site | Alcalá De Henares | Spain | 28805 | |
14 | Alcon Investigative Site | Oviedo | Spain | 33012 | |
15 | Alcon Investigative Site | San Sebastián | Spain | 20014 | |
16 | Alcon Investigative Site | Valencia | Spain | 46015 | |
17 | Alcon Investigative Site | Sutton | Carshalton | United Kingdom | SM5 1AA |
18 | Alcon Investigative Site | Brighton | United Kingdom | BN2 5BF | |
19 | Alcon Investigative Site | London | United Kingdom | EC1V2PD |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Alcon, a Novartis Division, Alcon, a Novartis Division
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ILJ466-P003