Telescope Exchange Study

Last updated: April 25, 2018
Sponsor: VisionCare, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopic Macular Degeneration

Aging

Macular Degeneration

Treatment

N/A

Clinical Study ID

NCT03011554
IMT-TES-2016
  • Ages > 65
  • All Genders

Study Summary

VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is indicated for monocular implantation to improve vision in eyes of patients at least 65 years of age with severe to profound vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration (AMD).

Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular lens placement are currently contraindicated for telescope surgery.

These patients have no viable therapy available to improve their vision.

The objective of the TES pilot study is to evaluate the safety and effectiveness of implanting the intraocular telescope for improving vision in patients with bilateral end-stage age- related macular degeneration who are pseudophakic.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have retinal findings of geographic atrophy or disciform scar with foveal involvementas determined by FA

  • Be age 65 or older

  • Have BCDVA between 20/160 to 20/800 (inclusive) on ETDRS chart

  • Be pseudophakic in the eye selected for telescope implantation

  • Agree to undergo pre-surgery training with a low vision specialist

  • Achieve at least a 5-letter improvement on the ETDRS chart with an external telescope

  • Agree to participate in postoperative vision training with a low vision specialist.

  • Patients must be able to provide and sign a voluntary informed consent.

  • Patients must not meet any of the exclusion criteria below.

Exclusion

Exclusion Criteria:

  • Stargardt's macular dystrophy

  • Cognitive impairment that would interfere with the ability to understand instructions,follow directions, or prevent proper visual training/rehabilitation with the device.

  • Any ophthalmic pathology that compromises fellow-eye peripheral vision

  • A history of steroid-responsive rise in intraocular pressure (IOP), uncontrolledglaucoma, or preoperative IOP >22mmHg while on maximum medication

  • Known sensitivity to planned study concomitant medications.

  • An ocular condition that predisposes the patient to eye rubbing.

  • Patients participating in any other ophthalmic drug or device clinical trial duringthe time of this clinical investigation.

  • Operative eye with:

  • Evidence of active CNV or treatment of CNV within 6 months

  • IOLs of the following types: PMMA, Crystalens, Tetraflex, Synchrony.

  • Central anterior chamber depth (ACD) < 3.0 mm; measurement of the ACD should betaken from the posterior surface of the cornea (endothelium) to the anteriorsurface of the IOL.

  • Axial length < 21 mm or >27 mm

  • Endothelial cell density (ECD) lower than 2300 cells/mm2 for subjects between theages 65-69, lower than 2000 cells/mm2 for subjects between the ages of 70-74, andlower than 1800 cells/mm2 for subjects 75 years old or greater.

  • Corneal stromal or endothelial dystrophies, including guttata

  • History of intraocular or corneal surgery (including DSEK) except cataractremoval and IOL placement

  • History of complicated cataract surgery

  • Compromised capsular bag (previous YAG posterior capsulotomy, evidence oftearing)

  • History of Radial Keratotomy

  • Inflammatory ocular disease

  • Pseudoexfoliation or zonular weakness

  • Diabetic retinopathy

  • Untreated retinal tears

  • Retinal vascular disease

  • Optic nerve disease

  • A history of retinal detachment

  • Intraocular tumor

  • Retinitis pigmentosa

  • Prior or expected ophthalmic related surgery within 30 days preceding telescopeimplantation

  • Any medical or ophthalmic condition that in the opinion of the investigatorrenders the subject unsuitable for participation in the study

Study Design

Total Participants: 75
Study Start date:
March 22, 2017
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Retinal Consultants of AZ

    Phoenix, Arizona 85014
    United States

    Active - Recruiting

  • UC Irvine, Gavin Herbert Eye Institute

    Irvine, California 92697
    United States

    Active - Recruiting

  • Loma Linda University Medical Center

    Loma Linda, California 92354
    United States

    Active - Recruiting

  • Eye Physicians of Long Beach

    Long Beach, California 90808
    United States

    Active - Recruiting

  • Eye Care of San Diego

    San Diego, California 92103
    United States

    Active - Recruiting

  • Orange County Retina

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Sarasota Retina Institute

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Minnesota Eye Consultants

    Minnetonka, Minnesota 55305
    United States

    Active - Recruiting

  • Associated Eye Care

    Stillwater, Minnesota 55082
    United States

    Active - Recruiting

  • St. John's Clinic - Eye Specialists. Mercy

    Springfield, Missouri 65804
    United States

    Active - Recruiting

  • Eye Associates of New Mexico Vision Research Center

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Eye Specialty Group

    Memphis, Tennessee 38120
    United States

    Active - Recruiting

  • Cornea Consultants of Texas

    Fort Worth, Texas 76107
    United States

    Active - Recruiting

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