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Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models

Primary Purpose

Age Related Cataracts

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vivinex XY1
Vivinex XY1A
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

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
  • Age 40 and older
  • Astigmatism of at least 0.75Diopters in one eye
  • Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

  • Diabetes mellitus
  • Pseudoexfoliation syndrome
  • Systemical anticoagulation
  • Antiphlogistic therapy
  • Antiglaucomatosa
  • Uncontrolled systemic or ocular disease
  • Preceding ocular surgery or trauma
  • Intraoperative complications
  • Pregnancy/Nursing
  • Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Vivinex XY1

    Vivinex XY1A

    Arm Description

    Implantation of an intraocular lens Hoya Vivinex XY1

    Implantation of an intraocular lens Hoya Vivinex XY1A

    Outcomes

    Primary Outcome Measures

    Number of FBGC (foreign body giant cells) (slitlamp examination)
    The number of foreign body giant cells on the IOLs will be assessed.

    Secondary Outcome Measures

    Incidence of Monocytes (slitlamp examination)
    The number of monocytes on the IOLs will be assessed. The following classification will be used: + = fewer than 10 cells/mm2; ++ = 10 to 25 cells/mm2; +++ = more than 25 cells/mm2
    PCO Score (slitlamp examination)
    Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO)
    Grade of Anterior Fibrosis (slitlamp examination)
    Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
    Anterior chamber reaction (slitlamp examination)
    Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively)

    Full Information

    First Posted
    January 10, 2020
    Last Updated
    March 8, 2021
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04230629
    Brief Title
    Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
    Official Title
    Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 15, 2021 (Anticipated)
    Primary Completion Date
    December 30, 2021 (Anticipated)
    Study Completion Date
    June 30, 2022 (Anticipated)

    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 the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH. A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) 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 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.
    Masking
    ParticipantInvestigator
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vivinex XY1
    Arm Type
    Active Comparator
    Arm Description
    Implantation of an intraocular lens Hoya Vivinex XY1
    Arm Title
    Vivinex XY1A
    Arm Type
    Active Comparator
    Arm Description
    Implantation of an intraocular lens Hoya Vivinex XY1A
    Intervention Type
    Device
    Intervention Name(s)
    Vivinex XY1
    Intervention Description
    Implantation of an intraocular lens Hoya Vivinex XY1
    Intervention Type
    Device
    Intervention Name(s)
    Vivinex XY1A
    Intervention Description
    Implantation of an intraocular lens Hoya Vivinex XY1A
    Primary Outcome Measure Information:
    Title
    Number of FBGC (foreign body giant cells) (slitlamp examination)
    Description
    The number of foreign body giant cells on the IOLs will be assessed.
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    Incidence of Monocytes (slitlamp examination)
    Description
    The number of monocytes on the IOLs will be assessed. The following classification will be used: + = fewer than 10 cells/mm2; ++ = 10 to 25 cells/mm2; +++ = more than 25 cells/mm2
    Time Frame
    5 months
    Title
    PCO Score (slitlamp examination)
    Description
    Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO)
    Time Frame
    5 months
    Title
    Grade of Anterior Fibrosis (slitlamp examination)
    Description
    Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
    Time Frame
    5 months
    Title
    Anterior chamber reaction (slitlamp examination)
    Description
    Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively)
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned Age 40 and older Astigmatism of at least 0.75Diopters in one eye Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: Diabetes mellitus Pseudoexfoliation syndrome Systemical anticoagulation Antiphlogistic therapy Antiglaucomatosa Uncontrolled systemic or ocular disease Preceding ocular surgery or trauma Intraoperative complications Pregnancy/Nursing Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rupert Menapace
    Phone
    0140400
    Ext
    66300
    Email
    rupert.menapace@meduniwien.ac.at

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models

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