A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD

Overview

Evaluation of pre and post-implantation management of patients with end-stage age-related macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under CE Mark indicated use. This study is designed to evaluate in particular the optimal parameters for patient selection for use of this device in routine clinical practice.

Full Title of Study: “A Prospective Multicenter Clinical Study of the Implantable Miniature Telescope* in Patients With Central Vision Impairment Associated With AMD: IMT-UK Protocol (*IMT by Dr. Isaac Lipshitz)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2011

Interventions

  • Device: Telescope prosthesis
    • Monocular implantation of the telescope prosthesis after cataract extraction

Arms, Groups and Cohorts

  • Experimental: I

Clinical Trial Outcome Measures

Primary Measures

  • Best-Corrected Visual Acuity
    • Time Frame: 1 year

Secondary Measures

  • Quality of Life
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

CE Mark approved indication of use which includes

  • At least 55 years of age – Bilateral visual impairment due to geographic atrophy or disciform scars – Evidence of cataract Exclusion Criteria:

  • Active CNV (or 'wet' AMD) – Prior cataract or refractive surgery in the study eye

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VisionCare, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Giuliana Silvestri, MD FRCP FRCS, Principal Investigator, Royal Hospitals, Belfast Health & Social Care Trust

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.