A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD
Not Applicable
Completed
- Conditions
- End Stage Macular Degeneration
- Interventions
- Device: Telescope prosthesis
- Registration Number
- NCT00555165
- Lead Sponsor
- VisionCare, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description I Telescope prosthesis -
- Primary Outcome Measures
Name Time Method Best-Corrected Visual Acuity 1 year
- Secondary Outcome Measures
Name Time Method Quality of Life 1 year
Trial Locations
- Locations (4)
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, United Kingdom