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Evaluation of the Rotational Stability

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intraocular lens
Sponsored by
Nidek Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

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

Inclusion Criteria:

  • Adults, 18 years or older
  • Subject who diagnosed unilateral or bilateral age-related cataract.
  • Potential postoperative BCVA of 0.2 log MAR (0.63) or better.
  • Calculated IOL power in within the range of investigational IOL.
  • Subject is able to understand, agree and sign the informed consent statement.
  • Subject is able and willing to comply with the postoperative follow-up examination schedule.

Exclusion Criteria:

  • Uncontrolled systemic or ocular disease.
  • Extremely shallow anterior chamber.
  • Previous intraocular and corneal surgery.
  • Traumatic cataract.
  • Pregnancy or lactation.
  • Concurrent participation in another drug and device clinical investigation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    one group

    Arm Description

    one group receiving NIDEK intraocular lens

    Outcomes

    Primary Outcome Measures

    The intraocular lens rotation
    The angle of the intraocular rotation.

    Secondary Outcome Measures

    visual acuity
    Distance BCVA
    Adverse event
    severity and causal relationship

    Full Information

    First Posted
    June 16, 2017
    Last Updated
    June 6, 2023
    Sponsor
    Nidek Co. LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03247751
    Brief Title
    Evaluation of the Rotational Stability
    Official Title
    Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    August 2017 (Actual)
    Study Completion Date
    November 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nidek Co. LTD.

    4. Oversight

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

    5. Study Description

    Brief Summary
    To evaluate rotational stability of the investigational device implanted after cataract surgery.
    Detailed Description
    The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.

    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
    95 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    one group
    Arm Type
    Experimental
    Arm Description
    one group receiving NIDEK intraocular lens
    Intervention Type
    Device
    Intervention Name(s)
    intraocular lens
    Intervention Description
    Implant NIDEK intraocular lens after cataract surgery
    Primary Outcome Measure Information:
    Title
    The intraocular lens rotation
    Description
    The angle of the intraocular rotation.
    Time Frame
    postoperative 6 months
    Secondary Outcome Measure Information:
    Title
    visual acuity
    Description
    Distance BCVA
    Time Frame
    postoperative 6 months
    Title
    Adverse event
    Description
    severity and causal relationship
    Time Frame
    postoperative 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults, 18 years or older Subject who diagnosed unilateral or bilateral age-related cataract. Potential postoperative BCVA of 0.2 log MAR (0.63) or better. Calculated IOL power in within the range of investigational IOL. Subject is able to understand, agree and sign the informed consent statement. Subject is able and willing to comply with the postoperative follow-up examination schedule. Exclusion Criteria: Uncontrolled systemic or ocular disease. Extremely shallow anterior chamber. Previous intraocular and corneal surgery. Traumatic cataract. Pregnancy or lactation. Concurrent participation in another drug and device clinical investigation.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluation of the Rotational Stability

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