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I. Kozak, S. F. Oster, M. A. Cortes, K. Hartmann, J. Kim, A. Kampik, A. S. Neubauer, W. R. Freeman; Clinical Treatment Accuracy in Diabetic Macular Edema Using Navigated Laser Photocoagulator Navilas®: A Multicentered Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2010;51(13):4266.
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To evaluate accuracy of a new tracking retinal laser photocoagulator with integrated digital fundus imaging (live color fundus photos, red-free and infra-red imaging and fluorescein angiography) and eye-tracking capabilities in the treatment of diabetic retinopathy and diabetic macular edema (DME).:
A multicenter clinical study of 56 eyes of 42 patients with diabetic retinopathy treated by NAVILAS®. The Imaging phase of the study included color fundus photos and fluorescein angiograms (FA) that were taken digitally. The Planning phase included graphically marking future treatment areas (microaneurysms for single spot focal treatment and areas of diffuse leakage for grid pattern photocoagulation) on the acquired FA. This was done with a either 30 or 50° field of view. In the Treatment phase the pre-positioned points were displayed and overlaid on the live fundus image during the actual treatment with photocoagulation laser. NAVILAS® automatically advanced the aiming beam from marked site to the next after each photocoagulation spot until they were all treated. Eye-tracking compensated for patient’s eye movements. In the Documentation phase color fundus images were taken from each eye after treatment. Pre-treatment marked areas on FA were overlayed to post-treatment laser burns on the color fundus images and treatment accuracy was calculated. Independent observers evaluated the images to determine if the retinal opacification after treatment overlapped the targeted microaneurysm. Four eyes with DME treated with standard contact lens protocol served as controls.
There were no complications during or after photocoagulation treatment. We analyzed accuracy of 100 random focal targeted spots and found that the NAVILAS® system achieved a microaneurysm hit rate of 86% when the placement of the treatment circle was centered by the operating surgeon on the microaneurysm. Off center targeting (human error) resulted in a lower hit rate of 82%. The accuracy for control group was 67%.
NAVILAS® achieves high treatment accuracy rate in photocoagulation of diabetic retinopathy lesions. Precise manual pre-positioning of treatment areas by the surgeon is crucial for accurate photocoagulation of these lesions and maximizing treatment efficacy.
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