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

NCT ID: NCT00976235

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Macular Degeneration

Keywords

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Macular Degeneration Visual Impairment Quality of Life Telescope Prosthesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IMT

Group Type EXPERIMENTAL

IMT - Implantable Miniature Telescope

Intervention Type DEVICE

Implantation of the telescope prosthesis (performed under the initial study)

Interventions

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IMT - Implantable Miniature Telescope

Implantation of the telescope prosthesis (performed under the initial study)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VisionCare, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Retina Centers P.C.

Tucson, Arizona, United States

Site Status

University of California at Irvine

Irvine, California, United States

Site Status

Altos Eye Physician

Los Altos, California, United States

Site Status

Doheny Retina Institute - University of Southern California

Los Angeles, California, United States

Site Status

Sarasota Retinal Institute

Sarasota, Florida, United States

Site Status

Emory Eye Center

Atlanta, Georgia, United States

Site Status

Kraft Eye Institute

Chicago, Illinois, United States

Site Status

Paducah Retinal Center

Paducah, Kentucky, United States

Site Status

Wilmer Ophthalmological Institute

Baltimore, Maryland, United States

Site Status

Retina Group of Washington

Chevy Chase, Maryland, United States

Site Status

Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

W.K. Kellogg Eye Center

Ann Arbor, Michigan, United States

Site Status

Associated Retinal Consultants

Royal Oak, Michigan, United States

Site Status

Associated Eye Care

Stillwater, Minnesota, United States

Site Status

Discover Vision Centers

Independence, Missouri, United States

Site Status

Manhattan Eye & Ear

New York, New York, United States

Site Status

Southeast Clinical Research

Charlotte, North Carolina, United States

Site Status

Duke University Eye Center

Durham, North Carolina, United States

Site Status

Retina Associates of Cleveland

Beachwood, Ohio, United States

Site Status

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, United States

Site Status

Fine, Hoffman & Packer

Eugene, Oregon, United States

Site Status

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Vitreoretinal Foundation

Memphis, Tennessee, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Medical Center Ophthalmology

San Antonio, Texas, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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IMT-002-LTM

Identifier Type: -

Identifier Source: org_study_id