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.