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In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens

Sponsor
AST Products, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04971863
Collaborator
Hospital Universitario La Fe (Other)
300
Enrollment
1
Location
3.1
Anticipated Duration (Months)
98.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to evaluate the 24 month postoperative incidence and intensity of posterior capsular opacity in patients submitted to cataract surgery and implanted with a hydrophobic monofocal IOL.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study is a two-arm masked clinical evaluation study of incidence of PCO after successful bilateral cataract surgery with implantation of a monofocal IOL. Subjects will be assessed 24 months after IOL implantation. Clinical evaluations will include incidence of adverse events, patient satisfaction questionnaire, as well as measurements of visual performance, optical quality, presence and intensity of PCO, presence and intensity of IOL glistening.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens. Two-year Follow-up
    Actual Study Start Date :
    Mar 30, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Clareon Monofocal IOL

    Patients bilaterally implanted with the Clareon monofocal IOL
    Asqelio Monofocal IOL

    Patients bilaterally implanted with the Asqelio monofocal IOL

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Posterior capsular opacity [24 months after IOL implantation]

      Incidence of PCO

    2. Intensity of Posterior capsular opacity [24 months after IOL implantation]

      Intensity of PCO determined using LOCSIII Classification System

    Secondary Outcome Measures

    1. Visual acuity [1 month, 6 months, 12 months and 24 months after IOL implantation]

      Best corrected distance visual acuity in LogMAR units using the ETDRS chart

    2. Refraction [1 month, 6 months, 12 months and 24 months after IOL implantation]

      Residual refractive error in diopters determined objectively

    3. Optical quality [24 months after IOL implantation]

      Higher-order wavefront aberrations determined using a clinical wavefront analyzer

    4. Incidence of Glistening [24 months after IOL implantation]

      Incidence of IOL glistening

    5. Intensity of Glistening [24 months after IOL implantation]

      Intensity of IOL glistening

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects 22 years or older submitted to cataract surgery in at least 1 eye and implanted with Asqelio monofocal or Clareon monofocal IOL
    Exclusion Criteria:

    • Any pathology reducing potential best-corrected visual acuity beyond 0.30 LogMAR, including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely shallow anterior chamber, microphthalmos, retinal detachment, severe recurrent anterior or posterior segment inflammation of unknown ethiology, iris neovascularization, uncontrolled glaucoma, clinically significant macular degeneration, or pseudoexfoliation diagnosis.

    • Previous ocular surgery

    • Rubella

    • Surgery motivated by traumatic cataract

    • Ocular trauma or refractive surgery

    • Any other systemic or ocular condition that, in the investigator's opinion, should exclude the subject from study

    • Requiring additional procedures due to intraoperatory complications, mechanical or surgical interventions for manipulating the pupil, excessive iris movility, significant vitreous loss, significant, anterior chamber hyphema, capsular annular breakage, or any other unrecognized ocular conditions that might compromise IOL positioning, as well as impossibility of locate the IOL in the capsular bag due to surgical complications.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario y Politécnico la Fe Valencia Spain

    Sponsors and Collaborators

    • AST Products, Inc.
    • Hospital Universitario La Fe

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AST Products, Inc.
    ClinicalTrials.gov Identifier:
    NCT04971863
    Other Study ID Numbers:
    • ASQM012021
    First Posted:
    Jul 22, 2021
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AST Products, Inc.
    posterior capsule opacitication
    incidence
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Mar 31, 2022