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Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

Sponsor
Alcon Research (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04330001
Collaborator
(none)
99
Enrollment
2
Locations
1
Arm
27.1
Anticipated Duration (Months)
49.5
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating IOL (FAIOL).

Condition or Disease Intervention/Treatment Phase
  • Device: Alcon Fluid Accommodating Intraocular Lens
  • Other: Top Con Autorefractor
 N/A

Detailed Description

Subjects will be expected to attend 10 office visits from screening to exit. The total expected duration of participation for each subject in this study is approximately 12 months. The second eye surgery will take place within 7-15 days from the date of the first implanted eye. The primary endpoint will be collected at Month 1, following the 2nd eye implant date.

Study Design

Study Type:
Interventional
Actual Enrollment :
99 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
Actual Study Start Date :
Dec 28, 2020
Actual Primary Completion Date :
Jun 8, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: FAIOL

Implantation of FAIOL in the capsular bag in the posterior chamber of the eye. The IOL is intended to be used over the lifetime of the subject.

Device: Alcon Fluid Accommodating Intraocular Lens
Intraocular lens intended to treat presbyopia by dynamically adjusting power, resulting in a continuous range of vision from distance to near.
Other Names:
  • FAIOL
  • FluidVision MX Accommodating IOL

    • Other: Top Con Autorefractor
    Device intended to automatically determine the focusing characteristics of the eye

    Outcome Measures

    Primary Outcome Measures

    1. Repeatability of objective refraction [Month 1 (post 2nd eye implant)]

      Two assessments of objective refraction (sphere, cylinder, and spherical equivalent) using auto refraction will be made on the same day. Repeatability of objective refraction will be evaluated using the Intra-class correlation coefficient (ICC), separately by eye. ICC is evaluated as the proportion of all variation that is not due to measurement error. Higher values of ICC indicate lower error variance and hence better repeatability. Repeatability of objective refraction will be assessed with and without cycloplegia (temporary paralysis of the ciliary muscle).

    Eligibility Criteria

    Criteria

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

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

    • 22 years of age or older

    • Bilateral cataracts

    • Corneal astigmatism ≤ 1.25 D

    • Clear intraocular media other than cataract

    • Other protocol-specified inclusion criteria may apply.

    Exclusion Criteria:
    • Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:

    1. are currently pregnant,

    2. have a positive urine pregnancy test result at V0,

    3. intend to become pregnant during the study period,

    4. are breast-feeding.

    • Subjects taking medications that may affect accommodation, confound the outcome, or as per the Investigator's opinion may increase the risk to the subject

    • Glaucoma

    • Significant corneal or retinal abnormalities, per the Investigator's opinion, or other disease or pathology other than cataract expected to reduce postoperative vision

    • Monocular patient, significant permanent visual function loss, or binocular vision anomalies as evaluated by specific testing

    • Previous corneal procedure (such as LASIK, keratotomy, LRI) or plans to have additional corneal procedures during the study

    • Systemic disease that could increase the operative risk or confound the outcome

    • Other protocol-specified exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Investigator 8071 San Salvador El Salvador 4625
    2 Alcon Investigator 8165 Panamá Panama

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Operation Lead CDMA Surgical, Alcon Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT04330001
    Other Study ID Numbers:
    • ILR286-E003
    First Posted:
    Apr 1, 2020
    Last Update Posted:
    Jul 20, 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:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Alcon Research
    IOL
    Cataract
    Accommodation
    Additional relevant MeSH terms:
    Presbyopia
    Aphakia

    Study Results

    No Results Posted as of Jul 20, 2022