A Long-Term Monitoring Study of the IMT-002 Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
End Stage Macular Degeneration	Device: IMT - Implantable Miniature Telescope	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Further study details as provided by VisionCare Ophthalmic Technologies, Inc.:

Primary Outcome Measures:

Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures) [ Time Frame: 5 years from implantation ] [ Designated as safety issue: Yes ]

Enrollment:	129
Study Start Date:	June 2006
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IMT	Device: IMT - Implantable Miniature Telescope Implantation of the telescope prosthesis (performed under the initial study)

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.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976235

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Locations

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

Sponsors and Collaborators

VisionCare Ophthalmic Technologies, Inc.

More Information

No publications provided

Responsible Party:	VisionCare Ophthalmic Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00976235 History of Changes
Other Study ID Numbers:	IMT-002-LTM
Study First Received:	September 10, 2009
Last Updated:	December 19, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by VisionCare Ophthalmic Technologies, Inc.:

Macular Degeneration
Visual Impairment
Quality of Life
Telescope Prosthesis

Additional relevant MeSH terms:

Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013