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Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)

Sponsor
AcuFocus, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05758883
Collaborator
(none)
343
Enrollment
21
Locations
10.6
Anticipated Duration (Months)
16.3
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A prospective, multi-center, open-label, single-group, post-approval follow-up study of IC-8 Apthera intraocular lens (IOL) subjects previously implanted with the IC-8 Apthera IOL in the Investigational Device Exemption (IDE) clinical study (G180075). All subjects will undergo one scheduled study visit, which is the 3-year post IC-8 Apthera IOL implantation visit. There is one study group: subjects enrolled in the US IDE study (G180075) and implanted with the IC-8 Apthera IOL.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    343 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post-approval Follow-up Study of the IC-8 Apthera IOL
    Actual Study Start Date :
    Jan 12, 2023
    Anticipated Primary Completion Date :
    Nov 30, 2023
    Anticipated Study Completion Date :
    Nov 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    IC-8 Apthera intraocular lens (IOL) Group

    Patients previously enrolled in the IC-8 Apthera IOL Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL.

    Outcome Measures

    Primary Outcome Measures

    1. Rates of secondary surgical interventions (SSIs) [3 years post IC-8 Apthera IOL implantation]

      Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit

    2. Rates of other serious adverse events [3 years post IC-8 Apthera IOL implantation]

      Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit

    3. Rates of ocular adverse events [3 years post IC-8 Apthera IOL implantation]

      Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit

    4. Rates of subjective visual disturbances [3 years post IC-8 Apthera IOL implantation]

      Rates of subjective visual disturbances will be assessed using responses to patient Reported Outcomes (PRO) and responses to non-directed question(s)

    Other Outcome Measures

    1. Monocular best-corrected distance visual acuity (BCDVA) in IC-8 Apthera eyes and fellow eyes [3 years post IC-8 Apthera IOL implantation]

      Monocular best-corrected distance visual acuity will be assessed at the Study visit in the IC-8 Apthera intraocular lens (IOL) eyes and in the fellow eyes

    2. Rate of intraocular lens (IOL) removals due to visual/optical reasons in the IC-8 Apthera eyes and fellow eyes [3 years post IC-8 Apthera IOL implantation]

      Rate of intraocular lens (IOL) removals (based on eyes with events) will be assessed at the Study visit in the IC-8 Apthera IOL eyes and in the fellow eyes

    3. Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA) [3 years post IC-8 Apthera IOL implantation]

      Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes

    4. Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA) [3 years post IC-8 Apthera IOL implantation]

      Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes

    5. Uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) in IC-8 Apthera eyes and the fellow eyes in postoperative Manifest Refraction Spherical Equivalent (MRSE) groups [3 years post IC-8 Apthera IOL implantation]

      Uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) in IC-8 Apthera eyes and the fellow eyes may be evaluated in postoperative Manifest Refraction Spherical Equivalent groups: -1.01 D to more myopic, -1.00 D to -0.50 D, -0.49 D to -0.25 D, -0.24 D to 0.00 D, +0.01 D to +0.25 D, +0.26 D to more hyperopic.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)

    • Able to comprehend and have signed a statement of informed consent

    • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)

    Exclusion Criteria:
    • There are no exclusion criteria for this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center Tucson Arizona United States 85704
    2 Empire Eye & Laser Center Bakersfield California United States 93309
    3 Harvard Eye Associates Laguna Hills California United States 92653
    4 Altos Eye Physicians Los Altos California United States 94024
    5 Advanced Vision Care Los Angeles California United States 90067
    6 Eye Center of Northern Colorado Fort Collins Colorado United States 80525
    7 Eye Center of North Florida Panama City Florida United States 32405
    8 Chu Vision Institute Bloomington Minnesota United States 55420
    9 Pepose Vision Institute Saint Louis Missouri United States 63128
    10 Kugler Vision Omaha Nebraska United States 68118
    11 Alterman, Modi & Wolter Poughkeepsie New York United States 12603
    12 Physicians Protocol Greensboro North Carolina United States 27408
    13 Cleveland Eye Clinic Brecksville Ohio United States 44141
    14 Philadelphia Eye Associates Philadelphia Pennsylvania United States 19148
    15 Bucci Laser Vision Wilkes-Barre Pennsylvania United States 18702
    16 Vance Thompson Vision Sioux Falls South Dakota United States 57108
    17 Baylor College of Medicine Houston Texas United States 77030
    18 Parkhurst NuVision San Antonio Texas United States 78229
    19 Hoopes Vision Draper Utah United States 84021
    20 Utah Eye Centers Ogden Utah United States 84403
    21 Virginia Eye Consultants Norfolk Virginia United States 23502

    Sponsors and Collaborators

    • AcuFocus, Inc.

    Investigators

    • Study Director: Magda Michna, Ph.D., AcuFocus, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AcuFocus, Inc.
    ClinicalTrials.gov Identifier:
    NCT05758883
    Other Study ID Numbers:
    • SAIL-101-PAS
    First Posted:
    Mar 8, 2023
    Last Update Posted:
    Mar 8, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Presbyopia

    Study Results

    No Results Posted as of Mar 8, 2023