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Acta Ophthalmologica 2017 PBM intervention After carefully and extensively review- ing the available literature and the so far proposed mode of actions of the different evaluated wavelengths, the authors decided to use a multiwave- length approach as this would poten- tially affect different cellular targets and should therefore confer greater benefit than a single wavelength. Two separate devices were required to pro- vide the multiple wavelengths. Both devices were FDA and Health Canada- approved for other conditions. The PBM intervention consisted of three distinct wavelengths in the yellow (590 nm), red (670 nm) and NIR (790 nm) range, chosen for their benefits on cellular targets involved in the disease process. We utilized LED units consisting of the Warp10 (Quantum Devices, New- ark, OH, USA) and the Gentlewaves (Light Bioscience, Virginia Beach, VA, USA) instruments. The PBM treatment parameters for the Warp10 were wave- length 670 15 nm delivering 50– 80 mW/cm2 (4–7.68 J/cm2) for 88 8 seconds, and for the Gentlewaves were wavelengths of 590 8 nm at 4 mW and 79060nm at 0.6mW, both for 35 seconds, pulsed at 2.5 Hz (250 mil- liseconds on, 150 milliseconds off) deliv- ering 0.1 J/cm2/treatment. All subjects were treated in both eyes with the two devices used sequentially at each treatment visit in nine sessions over a 3-week period. The treatment parameters delivered to the subjects were identical at each session. Study variables The primary clinical efficacy end-points were change from BL in BCVA and CS. The anatomical end-points were change in SD-OCT and FAF parameters. All subjects were assessed with stan- dardized ETDRS BCVA at a 4-m distance (Precision Vision, Woodstock, IL, USA) recorded as correct letters scored. The letter score reported con- forms to the WHO ICO report – Sydney April 2002 with a scale of 100 correct letters equivalent to logMAR: 0, decimal: 1.0 and Snellen: 20/20. Contrast sensitivity was assessed at 1.5, 3.0 and 6.0 cycles per degree (cpd) (Stereo Vision Optec 6500; func- tional acuity contrast test (FACT)) recorded as log CS for each cycle per degree. Subjects were tested by the same examiner at all visits under iden- tical conditions in his private practice office. Subjects were assessed with 20 9 20 high-resolution SD-OCT volume scans consisting of 25 section scans (250 lm distance between each scan, nine frames averaged) and with 488-nm FAF (Spec- tralis OCT, Heidelberg Engineering, Heidelberg, Germany). Subsequent SD-OCT scans were performed using the TruTrackTM (Heidelberg Engineer- ing GmbH, Heidelberg, Germany) func- tion to allow exact comparison of retina and drusen volume. Measurements included aligned mean central retinal thickness (CRT), aligned mean retinal volume (RV), GA lesion area, drusen/ reticular pseudodrusen (RPD) volume and mean central drusen/RPD thick- ness. Optical coherence tomography (OCT) and FAF scans were carefully reviewed by an independent imaging expert for the presence of drusen, RPD, GA, vitelliform lesions and for irregularity and disruption of the external limiting membrane (ELM), ellipsoid zone (EZ) and interdigitation zone (IZ) at each visit. Fundus autofluorescence images were reviewed for the presence of GA and vitelliform lesions. Drusen in SD-OCT scans were defined as focal deposits of divergent reflectivity and of variable size between the RPE and the Bruch membrane (Spaide & Curcio 2010). Drusenoid RPE detachments, defined as RPE elevations ≥350 lm, were included in the drusen volume measurements. Reticular pseudodrusen (RPD) were defined as small hyper-reflective depos- its located in the subretinal space (Spaide & Curcio 2010). Geographic atrophy on SD-OCT was identified when there was absence/loss of the RPE, the EZ and ELM together with enhanced choroidal signal and concomi- tant loss of the outer plexiform layer (Sayegh et al. 2011). Vitelliform lesions were identified when there were homo- genous hyper-reflective lesions located in the subretinal space (Chowers et al. 2015). The individual retinal layers were automatically segmented with the IN- BUILT software (1.9.10.0, Heidelberg Engineering, Germany) (Ctori & Huntjens 2015). The segmentation line of the Bruch’s membrane and the internal limiting membrane was inspected on each scan for correct alignment and manually corrected if needed to achieve valid RV and CRT values. The automated, adjusted seg- mentation line of the RPE was carefully examined for exact drusen alignment in each scan and in cases of incorrect segmentation adjusted (Fig. 1). The INBUILT software then automatically (A) (B) (C) Fig. 1. Representative images from two different patients showing characteristic pathologic changes. Semi-automated segmentation in optical coherence tomography (OCT) and geographic atrophy (GA) assessment in fundus autofluorescence (FAF) were performed. The left image (A) displays a representative drusen volume map of an AREDS 3 patient. Colour bars indicate ascending thickness values starting with 0 lm (black). The image in the middle (B) demonstrates the drusen alignment in one representative OCT section scan of the same patient. The right image (C) illustrates the assessment of the GA area using FAF at 488 nm wavelength in a patient with central involving GA of an AREDS 4 patient. The GA is measured by manually marking the area of homogenous hypo-autofluorescence using the INBUILT Heidelberg software (yellow line). e272PDF Image | Photobiomodulation reduces drusen in macular degeneration
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