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Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision

Primary Purpose

Inclusion Criteria

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"Scharioth" macula lens A45sml/A45smy
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inclusion Criteria

Eligibility Criteria

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

Inclusion Criteria:

  • Pseudophakic patients with non-active AMD that complain on near distance reading with a distance visual acuity better than 6/60.

Exclusion Criteria:

  • Exudative AMD with fluids, advanced glaucoma, advance visual field defects, aphakia, following complicated cataract surgery with PCIOL in the sulcus , phacodonesis, chronic uveitis, rubeosis iridis, central corneal opacity.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Add on lens

    Arm Description

    Outcomes

    Primary Outcome Measures

    near visual acuity

    Secondary Outcome Measures

    Full Information

    First Posted
    December 1, 2016
    Last Updated
    February 19, 2017
    Sponsor
    Rabin Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03061682
    Brief Title
    Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision
    Official Title
    Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2017 (Anticipated)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    January 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rabin Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Age related macular degeneration (AMD) is the leading cause of vision loss in patients older than 55 years old. AMD can present as dry AMD or wet AMD. In most cases AMD affects both eyes although in many cases it's asymmetrical as far as severity. Some patients require low vision aids to continue their daily life tasks. In the past a few attempts were made to use low vision intraocular lenses with corrective glasses without enough success. In addition telescopic and prismatic lenses were also tried. The difficulties with these lenses included low field of vision, unsatisfactory magnification, complicated surgical technique and high complication rates. Recently an add on lens was designed for the sulcus for implantation in pseudophakic AMD patients. The add on lens doubles the magnification of the central image dependent on the reading distance and the anatomy of the eye. The lens is acrylic hydrophobic and designed for implantation in the sulcus either in pseudophakic patients or in addition to an intraocular lens implanted during a routine cataract surgery. The lens is 13 mm wide with 4 symmetric haptics. The lens has 1.5 mm central part of 10 diopters and the rest of the lens has no optical power. Our purpose is to study implantation of the lenses in AMD patients to improve their reading ability and to improve their daily living.
    Detailed Description
    Study design Prospective study on implantation of the add on lenses in AMD patients. The study was approved by Rabin medical center IRB. Patients will be examined for best corrected visual acuity prior to the surgery at 6 meter and for reading at 40 and 15 cm. Improvement of the reading ability at 15 cm compared to 40 cm will predict the potential for vision improvement with the add on lens. Before the surgery patients will have a full ophthalmological examination. Patients will have axial length and keratometry examination using the biometry. The lens will be implanted in surgery through a 2.2 mm clear cornea and will be injected and positioned in the sulcus. Patients will be followed up at 1 day, 1 week, 4 weeks, 4 and 6 months following surgery. During follow up patients will undergo full ophthalmic exam and well as visual acuity both for distance and near.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Add on lens
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    "Scharioth" macula lens A45sml/A45smy
    Intervention Description
    Implantation of an add on intraocular lens to low vision patients
    Primary Outcome Measure Information:
    Title
    near visual acuity
    Time Frame
    last study visit - 6 months post surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pseudophakic patients with non-active AMD that complain on near distance reading with a distance visual acuity better than 6/60. Exclusion Criteria: Exudative AMD with fluids, advanced glaucoma, advance visual field defects, aphakia, following complicated cataract surgery with PCIOL in the sulcus , phacodonesis, chronic uveitis, rubeosis iridis, central corneal opacity.

    12. IPD Sharing Statement

    Learn more about this trial

    Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision

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