End Stage Macular Degeneration Clinical Trial
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)
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.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | May 2011 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 55 Years and older |
| Eligibility |
Inclusion Criteria: CE Mark approved indication of use which includes - At least 55 years of age - Bilateral visual impairment due to geographic atrophy or disciform scars - Evidence of cataract Exclusion Criteria: - Active CNV (or 'wet' AMD) - Prior cataract or refractive surgery in the study eye |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Royal Hospitals, Belfast Health & Social Care Trust | Belfast | |
| United Kingdom | Frimley Park Hospital NHS Trust | Frimley | Surrey |
| United Kingdom | King's College Hospital NHS Trust | London | |
| United Kingdom | Moorfields Eye Hospital NHS Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| VisionCare Ophthalmic Technologies, Inc. |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Best-Corrected Visual Acuity | 1 year | No | |
| Secondary | Quality of Life | 1 year | No |