A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD

VisionCare

Status: Completed

Conditions: End Stage Macular Degeneration

Treatments: Device: Telescope prosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00555165

IMT-UK

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

I

Experimental group

Treatment:

Device: Telescope prosthesis