Abstract
Purpose: :
To provide proof of concept for a pilot study using a new nanosecond laser based treatment in early Age-related Macular Degeneration (AMD) to reduce progression or even cause regression of disease.
Methods: :
The study design involved treating one eye with the nanosecond retinal regenerative therapy (2RT) laser in patients with bilateral high risk early AMD, using the contra-lateral eye as a control. Subjects underwent a full clinical evaluation and undertook novel visual function testing: dark adaptation, flicker and colour thresholds, VA or drusen resolution in both eyes at baseline, prior to treatment and then at 1, 3, 6 months and 12 months post laser. The laser was applied in one session with twelve, subthreshold, 400um spots placed in a clock hour distribution, 1400um from the fovea in one eye.
Results: :
20 patients have been recruited and treated in one eye. 7 eyes have been tested out to 6 months. Of these 7 recruits, the treated eye improved in at least one parameter in 6 cases; dark adaptation (3), flicker (1) and colour thresholds, (3) VA (1) or drusen resolution (5). The fellow untreated eye improved in at least one parameter in 5 of 7 dark adaptation (3), flicker (1) and colour thresholds, (1) VA (1) or drusen resolution (5).
Conclusions: :
At 6 months post laser a large number of treated eyes, and untreated eyes were showing some signs of overall retinal function improvement. The dramatic effect seen in some subject’s fellow eye was not expected. We aim to treat 50 high risk eyes over the next year to complete the pilot study. It is anticipated that the 2RT laser will address the underlying cause of AMD which appears to be reduced flux across Bruch’s membrane. The laser design should enable the positive features of previous laser studies for early AMD to be harnessed without entertaining any of the negative effects such as neovascularization.
Clinical Trial: :
www.anzctr.org.au 00320905
Keywords: age-related macular degeneration • drusen • laser