Back to resultsA Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD
Primary Purpose
End Stage Macular Degeneration
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Telescope prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Macular Degeneration focused on measuring Macular Degeneration, Visual Impairment, Quality of Life, Implantable Telescope
Eligibility Criteria
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
Sites / Locations
- Frimley Park Hospital NHS Trust
- Royal Hospitals, Belfast Health & Social Care Trust
- Moorfields Eye Hospital NHS Trust
- King's College Hospital NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
I
Arm Description
Outcomes
Primary Outcome Measures
Best-Corrected Visual Acuity
Secondary Outcome Measures
Quality of Life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00555165
Brief Title
A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VisionCare, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Macular Degeneration
Keywords
Macular Degeneration, Visual Impairment, Quality of Life, Implantable Telescope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Telescope prosthesis
Intervention Description
Monocular implantation of the telescope prosthesis after cataract extraction
Primary Outcome Measure Information:
Title
Best-Corrected Visual Acuity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuliana Silvestri, MD FRCP FRCS
Organizational Affiliation
Royal Hospitals, Belfast Health & Social Care Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frimley Park Hospital NHS Trust
City
Frimley
State/Province
Surrey
ZIP/Postal Code
GU167UJ
Country
United Kingdom
Facility Name
Royal Hospitals, Belfast Health & Social Care Trust
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Moorfields Eye Hospital NHS Trust
City
London
ZIP/Postal Code
EC1V 1JN
Country
United Kingdom
Facility Name
King's College Hospital NHS Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD
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