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Jesse J. Jung, Jonathan Huz, Irene A. Barbazetto; Navilas Laser System Focal Laser Treatment for Diabetic Macular Edema - 1 year results of a pilot study. Invest. Ophthalmol. Vis. Sci. 2012;53(14):386.
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© ARVO (1962-2015); The Authors (2016-present)
To report the 12 months outcomes of Navigated Retina Laser Therapy (Navilas) automated focal therapy for diabetic macular edema (DME) in patients with suboptimal diabetic control.
Retrospective case series of 8 consecutive patients treated for DME with a single session of focal laser treatment using the Navilas system (OD-OS, Inc., San Francico, CA). Best-corrected visual acuity (VA) and largest subfield of macular thickness (LMT) by OCT (Stratus OCT, Carl Zeiss-Meditec Inc, Dublin, CA) were compared by single armed t-test.
Nine eyes of 8 patients (4 male; 4 female) with with an average age of 62.2 years (range 48-85 years) were included. All eyes were phakic; patients had an average hemoglobin A1c of 9.2 (range 7.8-11.7) at baseline and 9.0 (range 7.4-10.6) at 9 months; 5 patients were treated for hypertension. Six of the 9 eyes had intravitreal bevacizumab (Genentech Inc., San Fracisco, CA) injections prior to focal laser treatment with 1 patient having had more than 1 prior injection (total 3).Currently, 9 month data is reported and 12 month data is pending; at 9 months, mean VA improved from logMAR 0.62 (std dev 0.39) at baseline to 0.40 (std dev 0.27, p=0.03). 89% of eyes had stable or improved vision (gain > 1 line). Changes in vision of eyes treated with bevacizumab prior to and after focal laser therapy were approaching statistically significance (p=0.06), while the laser-only group was too small for statistical analysis. Mean LMT decreased from 358µm (std dev 67.02) at baseline to 337µm (std dev 74.60, p = 0.10), but the difference was not statistically significant. Three patients required an average of 6.3 (range 3-10) additional bevacizumab injections following Navilas treatment for persistent macular edema. One patient refused injection and received an additional focal laser treatment. All patients tolerated the procedures well and without any adverse events.
Focal laser treatment using the Navilas system for DME showed to be safe and well tolerated. Visual acuity showed statistically significant improvement in spite of poor glycemic control. Given the relative low number of Avastin injections following focal laser treatment, there may be a potential role for the Navilas system in reducing the re-treatment burden in this patient population. Future larger controlled trials are necessary to confirm these observations.
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