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Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses (VICTORI)

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AT LISA tri toric 939MP
Sponsored by
Carl Zeiss Meditec AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

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

Inclusion Criteria:

  • Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
  • Man or woman, over 50 years of age
  • Healthy eyes with bilateral cataract requiring surgical treatment for both eyes
  • Bilateral regular corneal astigmatism (confirmed by topography measurement)
  • Only patients requiring intraocular lenses of a power comprised between sphere +0.0 and +28.0 dioptres and between a cylindrical range of +1.0 to +4.0D in both eyes will be able to participate in the trial.
  • Biometry measurement/cataract density compatible with the IOLMaster evaluation
  • Bilateral uncomplicated cataract surgery and implantation into capsular bag by injector
  • Assured follow-up examinations

Exclusion Criteria:

  • Patients unable to meet the limitations of the protocol or likely of non cooperation during the trial,
  • Patients whose freedom is impaired by administrative or legal order,
  • Monophtalmic patient.
  • Previous ocular surgery, including corneal/refractive surgery,
  • Chronic or recurrent uveitis,
  • Acute ocular disease or external/internal infection,
  • Any kind of macular degeneration and impairment of retina (clinical diagnosis/OCT examination)
  • Diabetes with retinal changes,
  • Pseudoexfoliation syndrome
  • Pathologic myosis
  • Irregular astigmatism, especially keratoconus,
  • Endothelial corneal dystrophy
  • Glaucoma or IOP higher than 21mmHg under ocular hypertension treatment
  • Aniridia
  • Pseudophakia
  • Cornea guttata; keratoplasty
  • Amotio operation; anamnesis with vitreous surgery
  • Amblyopia
  • Intraocular tumours; endotamponade
  • Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR
  • Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
  • Pupil diameter over 6 mm in mesopic condition
  • Corneal opacity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    939MP

    Arm Description

    AT LISA tri toric 939MP intraocular lens

    Outcomes

    Primary Outcome Measures

    Best distance-corrected visual acuity for intermediate vision after bilateral implantation

    Secondary Outcome Measures

    Full Information

    First Posted
    December 5, 2016
    Last Updated
    January 25, 2018
    Sponsor
    Carl Zeiss Meditec AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02985723
    Brief Title
    Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses
    Acronym
    VICTORI
    Official Title
    Prospective Study to Evaluate the Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Carl Zeiss Meditec AG

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of the present study is to evaluate the postoperative visual acuity for distance, intermediate and near vision as well as the cylinder correction and the patient satisfaction after bilateral implantation of AT LISA tri toric 939MP IOLs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    939MP
    Arm Type
    Experimental
    Arm Description
    AT LISA tri toric 939MP intraocular lens
    Intervention Type
    Device
    Intervention Name(s)
    AT LISA tri toric 939MP
    Primary Outcome Measure Information:
    Title
    Best distance-corrected visual acuity for intermediate vision after bilateral implantation
    Time Frame
    12 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent Man or woman, over 50 years of age Healthy eyes with bilateral cataract requiring surgical treatment for both eyes Bilateral regular corneal astigmatism (confirmed by topography measurement) Only patients requiring intraocular lenses of a power comprised between sphere +0.0 and +28.0 dioptres and between a cylindrical range of +1.0 to +4.0D in both eyes will be able to participate in the trial. Biometry measurement/cataract density compatible with the IOLMaster evaluation Bilateral uncomplicated cataract surgery and implantation into capsular bag by injector Assured follow-up examinations Exclusion Criteria: Patients unable to meet the limitations of the protocol or likely of non cooperation during the trial, Patients whose freedom is impaired by administrative or legal order, Monophtalmic patient. Previous ocular surgery, including corneal/refractive surgery, Chronic or recurrent uveitis, Acute ocular disease or external/internal infection, Any kind of macular degeneration and impairment of retina (clinical diagnosis/OCT examination) Diabetes with retinal changes, Pseudoexfoliation syndrome Pathologic myosis Irregular astigmatism, especially keratoconus, Endothelial corneal dystrophy Glaucoma or IOP higher than 21mmHg under ocular hypertension treatment Aniridia Pseudophakia Cornea guttata; keratoplasty Amotio operation; anamnesis with vitreous surgery Amblyopia Intraocular tumours; endotamponade Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient Pupil diameter over 6 mm in mesopic condition Corneal opacity
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Piovella, Dr
    Organizational Affiliation
    CMA - Centro Microchirurgia Ambulatoriale
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses

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