Post-Market Clinical Investigation of the Clareon® IOL

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03316885
Collaborator
(none)
245
19
1
42.3
12.9
0.3

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
  • Device: Clareon® IOL
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

Study Type:
Interventional
Actual Enrollment :
245 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post-Market Clinical Investigation of the Clareon® IOL
Actual Study Start Date :
Mar 14, 2018
Actual Primary Completion Date :
Sep 23, 2021
Actual Study Completion Date :
Sep 23, 2021

Arms and Interventions

Arm Intervention/Treatment
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:
  • Model SY60WF
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 2 years post-implantation [Year 2 (second eye)]

    3. 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.

    4. UCDVA at 2 years post-implantation [Year 2 (second eye)]

    5. UCDVA at 3 years post-implantation [Year 3 (second eye)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • 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 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03316885
    Other Study ID Numbers:
    • ILJ466-P003
    First Posted:
    Oct 20, 2017
    Last Update Posted:
    Oct 4, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 4, 2021