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Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses (Acryvivi)

Primary Purpose

Age Related Cataracts

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alcon SN60WF
Hoya Vivinex
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age Related Cataracts

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
  • Age 50 and older
  • Visual potential in both eyes of 20/30 or better as determined by investigators estimation
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

  • Preceding intraocular surgery or ocular trauma
  • Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
  • Laser treatment
  • Uncontrolled systemic or ocular disease
  • Infectious disease
  • Pregnancy/Nursing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Alcon SN60WF

    Hoya Vivinex

    Arm Description

    Implantation of an intraocular lens Alcon SN60WF

    Implantation of an intraocular lens Hoya Vivinex

    Outcomes

    Primary Outcome Measures

    PCO score
    subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)

    Secondary Outcome Measures

    Visual Acuity
    UCDVA(uncorrected distance visual acuity), BCDVA (best corrected distance visual acuity)
    Fibrosis
    grade of fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
    Subjective glistening score
    neg, <10, 10-20, 20-30, 30-40, >40 uniform or localized
    YAG capsulotomy rate
    described subjectively at the slitlamp: was a YAG capsulotomy performed yes/no

    Full Information

    First Posted
    December 6, 2019
    Last Updated
    December 11, 2019
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04196673
    Brief Title
    Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses
    Acronym
    Acryvivi
    Official Title
    Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs. Acrysof SN60WF
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2015 (Actual)
    Primary Completion Date
    June 19, 2016 (Actual)
    Study Completion Date
    August 23, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type. A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Age Related Cataracts

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Alcon SN60WF
    Arm Type
    Experimental
    Arm Description
    Implantation of an intraocular lens Alcon SN60WF
    Arm Title
    Hoya Vivinex
    Arm Type
    Experimental
    Arm Description
    Implantation of an intraocular lens Hoya Vivinex
    Intervention Type
    Device
    Intervention Name(s)
    Alcon SN60WF
    Intervention Description
    Implantation of an intraocular lens Alcon SN60WF
    Intervention Type
    Device
    Intervention Name(s)
    Hoya Vivinex
    Intervention Description
    Implantation of an intraocular lens Hoya Vivinex
    Primary Outcome Measure Information:
    Title
    PCO score
    Description
    subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Visual Acuity
    Description
    UCDVA(uncorrected distance visual acuity), BCDVA (best corrected distance visual acuity)
    Time Frame
    3 years
    Title
    Fibrosis
    Description
    grade of fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
    Time Frame
    3 years
    Title
    Subjective glistening score
    Description
    neg, <10, 10-20, 20-30, 30-40, >40 uniform or localized
    Time Frame
    3 years
    Title
    YAG capsulotomy rate
    Description
    described subjectively at the slitlamp: was a YAG capsulotomy performed yes/no
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned Age 50 and older Visual potential in both eyes of 20/30 or better as determined by investigators estimation Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: Preceding intraocular surgery or ocular trauma Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.) Laser treatment Uncontrolled systemic or ocular disease Infectious disease Pregnancy/Nursing
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rupert Menapace, Prof. Dr.
    Organizational Affiliation
    Medical University of Vienna
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses

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