Trial Design |
Interventional multicentre randomised controlled trial. |
Study Aim |
The main goal of the study is to investigate the effectiveness, safety, and mechanisms of action of a novel implantable intraocular telescopic device in advanced AMD. We will also conduct a cost-effectiveness analysis.
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The specific objectives are to compare the effect of the telescopic implant at 12 months in terms of: Best corrected distance visual acuity; Other measures of visual function such as near acuity, reading speed and contrast sensitivity; Health-related and visual-related quality of life; Safety; Costs and cost-effectiveness; To explore whether patient ocular parameters such as scar size, and volume at site are associated with visual outcome; To assess the importance of Preferred Retinal Locus (PRL) and ocular dominance on outcomes; To evaluate the role of binocularity and visual summation on outcomes
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