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Zeiss® IOLMaster 700 Corneal Topography Module Comparison With Schwind's Sirius Corneal Topography® (VIMECT)

Primary Purpose

Cataract

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
measurement of axial length and keratometry by sonographers with a topographic module
Sponsored by
Edouard KOCH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cataract

Eligibility Criteria

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

Inclusion Criteria:

  • Men and Women Requiring CHV Cataract Surgery
  • Aged 18 or over
  • Insured under a social security scheme
  • Having been informed of the clinical study and having given oral express consent

Exclusion Criteria:

  • Person unable to express consent
  • Patient with a history of corneal dystrophy, corneal refractive surgery or keratoconus.
  • History of chronic corneal disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Corneal Topography with IOLMaster and Sirius topography.

    Arm Description

    The experimental group will have the two exams: the topography with the IOLMAster and the topography with Sirius topography.

    Outcomes

    Primary Outcome Measures

    keratometry measurements
    to show that the keratometry measurements obtained using the topography module integrated in the IOL Master 700 are consistent with those obtained by a standard topography in patients operated for cataract surgery. The measures will be: K1 (steepest corneal meridian), K2 (flattest corneal meridian), Kmax (central corneal keratometry), the unit of measurement is the diopter.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 3, 2022
    Last Updated
    August 22, 2022
    Sponsor
    Edouard KOCH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05414773
    Brief Title
    Zeiss® IOLMaster 700 Corneal Topography Module Comparison With Schwind's Sirius Corneal Topography®
    Acronym
    VIMECT
    Official Title
    Zeiss® IOLMaster 700 Corneal Topography Module Comparison With Schwind's Sirius Corneal Topography®
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    January 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Edouard KOCH

    4. Oversight

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

    5. Study Description

    Brief Summary
    In order to determine the intraocular lens to be implanted during cataract surgery, keratometry and axial length must be measured in preoperative. The axial length is obtained by ocular ultrasound mode B. Keratometry is obtained by means of an automatic refractometer or corneal topography. Currently, ultrasound scanners are being developed with a topography module to combine axial length and keratometry measurement. The investigators want to evaluate the corneal topography module of the Zeiss® IOL Master 700 biometer.

    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
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Corneal Topography with IOLMaster and Sirius topography.
    Arm Type
    Experimental
    Arm Description
    The experimental group will have the two exams: the topography with the IOLMAster and the topography with Sirius topography.
    Intervention Type
    Other
    Intervention Name(s)
    measurement of axial length and keratometry by sonographers with a topographic module
    Intervention Description
    measurement of axial length and keratometry by sonographers with a topographic module
    Primary Outcome Measure Information:
    Title
    keratometry measurements
    Description
    to show that the keratometry measurements obtained using the topography module integrated in the IOL Master 700 are consistent with those obtained by a standard topography in patients operated for cataract surgery. The measures will be: K1 (steepest corneal meridian), K2 (flattest corneal meridian), Kmax (central corneal keratometry), the unit of measurement is the diopter.
    Time Frame
    day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and Women Requiring CHV Cataract Surgery Aged 18 or over Insured under a social security scheme Having been informed of the clinical study and having given oral express consent Exclusion Criteria: Person unable to express consent Patient with a history of corneal dystrophy, corneal refractive surgery or keratoconus. History of chronic corneal disease

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Zeiss® IOLMaster 700 Corneal Topography Module Comparison With Schwind's Sirius Corneal Topography®

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