Real-World Study of Vivity Intraocular Lenses (IOLs)

Sponsor
Alcon Research (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04800016
Collaborator
(none)
65
1
1
36.8
1.8

Study Details

Study Description

Brief Summary

The primary objective of this clinical study is to assess the clinical performance of the AcrySof IQ Vivity Extended Vision IOL in a Chinese population.

Condition or Disease Intervention/Treatment Phase
  • Device: AcrySof IQ Vivity Extended Vision IOL
  • Procedure: Cataract surgery
N/A

Detailed Description

In this clinical study, subjects will be implanted with the AcrySof IQ Vivity Extended Vision IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 13 months. This study will be conducted in China.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)
Actual Study Start Date :
Jun 6, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vivity IOL

AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery

Device: AcrySof IQ Vivity Extended Vision IOL
UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near.
Other Names:
  • Model DFT015
  • Procedure: Cataract surgery
    Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL

    Outcome Measures

    Primary Outcome Measures

    1. Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye [Month 6 post second eye implantation]

      Intermediate visual acuity will be assessed at 66 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.

    2. Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye [Month 6 post second eye implantation]

      Near visual acuity will be assessed at 40 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye. .

    3. Incidence of ocular adverse events [Up to Month 12 post second eye implantation]

      Ocular adverse events will be reported.

    4. Incidence of secondary surgical interventions (SSIs) [Up to Month 12 post second eye implantation]

      Secondary surgical interventions will be reported.

    5. Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire) [Up to Month 12 post second eye implantation]

      Subjects will be surveyed using the QUVID questionnaire.

    Secondary Outcome Measures

    1. Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye [Month 6 post second eye implantation]

      Distance visual acuity will be assessed at 4 meters (m) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • Able to understand and sign an approved informed consent;

    • Willing and able to attend all scheduled study visits as required per protocol;

    • Diagnosed with cataracts in both eyes;

    • Pre-operative regular corneal astigmatism less than 1.0 diopter (D);

    • Planned bilateral cataract removal by phacoemulsification.

    • Other protocol-specified inclusion criteria may apply.

    Key Exclusion Criteria:
    • Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;

    • Clinically significant corneal diseases;

    • Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;

    • Previous intraocular surgery history;

    • Pregnancy or lactation during study or planning to be pregnant/lactating;

    • Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;

    • Other planned ocular surgical procedures;

    • Patients who can only undergo cataract surgery in one eye.

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hainan Bo'ao Super Hospital Co., Ltd. Qionghai Hainan China

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Trial Lead, Surgical, Alcon (China) Ophthalmic Product Co., Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT04800016
    Other Study ID Numbers:
    • ILI875-P002
    First Posted:
    Mar 16, 2021
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    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:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Alcon Research
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 12, 2022