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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976235
• Other study ID #: IMT-002-LTM
• Status: Completed
• Phase: N/A
• First received: September 10, 2009
• Last updated: November 1, 2017
• Start date: June 2006
• Est. completion date: May 2011

Study information

• Verified date: November 2017
• Source: VisionCare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Device:
• IMT - Implantable Miniature Telescope
Implantation of the telescope prosthesis (performed under the initial study)

Locations

Country	Name	City	State
United States	W.K. Kellogg Eye Center	Ann Arbor	Michigan
United States	Emory Eye Center	Atlanta	Georgia
United States	Wilmer Ophthalmological Institute	Baltimore	Maryland
United States	Retina Associates of Cleveland	Beachwood	Ohio
United States	Massachusetts Eye & Ear Infirmary	Boston	Massachusetts
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Southeast Clinical Research	Charlotte	North Carolina
United States	Retina Group of Washington	Chevy Chase	Maryland
United States	Kraft Eye Institute	Chicago	Illinois
United States	Duke University Eye Center	Durham	North Carolina
United States	Fine, Hoffman & Packer	Eugene	Oregon
United States	Baylor College of Medicine	Houston	Texas
United States	Discover Vision Centers	Independence	Missouri
United States	University of California at Irvine	Irvine	California
United States	Altos Eye Physician	Los Altos	California
United States	Doheny Retina Institute - University of Southern California	Los Angeles	California
United States	Vitreoretinal Foundation	Memphis	Tennessee
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee
United States	Manhattan Eye & Ear	New York	New York
United States	Dean A. McGee Eye Institute	Oklahoma City	Oklahoma
United States	Paducah Retinal Center	Paducah	Kentucky
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Associated Retinal Consultants	Royal Oak	Michigan
United States	Medical Center Ophthalmology	San Antonio	Texas
United States	Sarasota Retinal Institute	Sarasota	Florida
United States	Associated Eye Care	Stillwater	Minnesota
United States	Retina Centers P.C.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
VisionCare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)		5 years from implantation