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| Sponsored by: |
VisionCare Ophthalmic Technologies, Inc. |
|---|---|
| Information provided by: | VisionCare Ophthalmic Technologies, Inc. |
| ClinicalTrials.gov Identifier: | NCT00555165 |
Purpose
Evaluation of pre and post−implantation management of patients with end−stage age−related macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under CE Mark indicated use. This study is designed to evaluate in particular the optimal parameters for patient selection for use of this device in routine clinical practice.
| Condition | Intervention |
|---|---|
|
End Stage Macular Degeneration |
Device: Telescope prosthesis |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| Official Title: | A Prospective Multicenter Clinical Study of the Implantable Miniature Telescope* in Patients With Central Vision Impairment Associated With AMD: IMT-UK Protocol (*IMT by Dr. Isaac Lipshitz) |
| Estimated Enrollment: | 75 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | July 2009 |
| Arms | Assigned Interventions |
|---|---|
| I: Experimental |
Device: Telescope prosthesis
Monocular implantation of the telescope prosthesis after cataract extraction
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
CE Mark approved indication of use which includes
Exclusion Criteria:
Contacts and Locations| Contact: Carole Schreier | +1 4088729393 | carole@visioncareinc.net |
| Contact: Chet Kumar, DPT | +1 4088729393 |
| United Kingdom | |
| Royal Hospitals, Belfast Health & Social Care Trust | Recruiting |
| Belfast, United Kingdom, BT12 6BA | |
| Contact: Murali R Upendran | |
| Principal Investigator: Giuliana Silvestri, MD FRCS | |
| Moorfields Eye Hospital NHS Trust | Recruiting |
| London, United Kingdom, EC1V 1JN | |
| Contact: Tina Burman | |
| Principal Investigator: Mark Wilkins, MD FRCOphth | |
| Sub-Investigator: Adnan Tufail, MD MRCOphth | |
| King's College Hospital NHS Trust | Recruiting |
| London, United Kingdom, SE5 9RS | |
| Contact: Irene Kimm | |
| Principal Investigator: Victor Chong, MD, FRCOphth | |
| Principal Investigator: Emma Hollick, MD, FRCOphth | |
| Principal Investigator: | Giuliana Silvestri, MD FRCP FRCS | Royal Hospitals, Belfast Health & Social Care Trust |
More Information
| Study ID Numbers: | IMT-UK |
| Study First Received: | November 5, 2007 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00555165 |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
Macular Degeneration Visual Impairment Quality of Life Implantable Telescope |
|
Eye Diseases Quality of Life Retinal Degeneration Macular Degeneration |
Retinal Diseases Vision, Low Retinal degeneration |
