A Long-Term Monitoring Study of the IMT-002 Patients

November 1, 2017 updated by: VisionCare, Inc.

Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients

This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Retina Centers P.C.
    • California
      • Irvine, California, United States, 92697
        • University of California at Irvine
      • Los Altos, California, United States, 94024
        • Altos Eye Physician
      • Los Angeles, California, United States, 90033
        • Doheny Retina Institute - University of Southern California
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Retinal Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Eye Center
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Kraft Eye Institute
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Paducah Retinal Center
    • Maryland
      • Baltimore, Maryland, United States, 21287-9277
        • Wilmer Ophthalmological Institute
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye & Ear Infirmary
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • W.K. Kellogg Eye Center
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants
    • Minnesota
      • Stillwater, Minnesota, United States, 55082
        • Associated Eye Care
    • Missouri
      • Independence, Missouri, United States, 64055
        • Discover Vision Centers
    • New York
      • New York, New York, United States, 10021
        • Manhattan Eye & Ear
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Southeast Clinical Research
      • Durham, North Carolina, United States, 27710
        • Duke University Eye Center
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Retina Associates of Cleveland
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean A. McGee Eye Institute
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Fine, Hoffman & Packer
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 78240
        • Vitreoretinal Foundation
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have participated in the IMT-002 trial.
  • Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study.
  • Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

  • Patients who have not participated in the IMT-002 trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMT
Device: IMT - Implantable Miniature Telescope
Implantation of the telescope prosthesis (performed under the initial study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)
Time Frame: 5 years from implantation
5 years from implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VisionCare, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMT-002-LTM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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