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

Sponsor

VisionCare, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00976235

Collaborator

(none)

129

Enrollment

Locations

Arm

Duration (Months)

4.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Device: IMT - Implantable Miniature Telescope	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: IMT

Device: IMT - Implantable Miniature Telescope

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

Outcome Measures

Primary Outcome Measures

Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures) [5 years from implantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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