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Acta Ophthalmologica 2017 statistically significant and clinically relevant (Elliott & Sheridan 1988). Based on 95% confidence intervals, a change in acuity of logMAR 0.2 (10 letters) from BL is unlikely to be related to measurement variability (Beck et al. 2003). Interestingly, it would appear that those with good to fair vision (20/30– 20/80) benefited the most from PBM therapy. However, patients with BCVA both better and worse than this group at BL also showed benefit. This seems reasonable considering the ceiling effect in patients with a BCVA better than 20/32 and the fact that patients with a BL score worse than 20/80 already exhibit irreversible damage of the outer retina in the fovea. Improvements in CS were also significant and correlated to the improvements in BCVA. The significant drusen reduction in association with functional improve- ment is particularly compelling. Our data clearly show a decrease in drusen volume and mean central drusen thick- ness. Although drusen formation and regression are in a constant process of change, we know from previous studies that the drusen area tends to increase even during a short period of time (Gregori et al. 2014). A short-term follow-up study analysing drusen area progression over 6 months has demon- strated a progression of 0.031 and 0.029 mm2 on SD-OCT and CF, respectively (Gregori et al. 2014). Our data showed a mean regression of drusen volume of 0.03 mm3 over a period of 3 months. While drusen regression and resolution can leave behind GA (Suzuki et al. 2015), drusen can also collapse and vanish without contributing to further photoreceptor and RPE irregularity and loss. In this study, none of the eyes developed new onset of EZ or IZ irregularities or new formation of RPE loss, indicating that drusen regressed without contributing to new GA formation. Increase in drusen area (Sarraf et al. 1999) has previously found to be a significant predictive factor for the onset of late-stage AMD and the presence of RPD has been associated with a higher risk of late-stage AMD (Marsiglia et al. 2013; Alten & Eter 2015). Patients with RPD in this case series showed similar, significant treatment responses suggest- ing regression of disease. Higher power lasers as well as sub- threshold lasers have been used to affect drusen regression but did not show evidence to reduce the risk of developing CNV or GA. A meta- analysis on laser studies evaluating the functional and morphological effi- cacy of laser treatment in AMD has shown that laser may be effective to induce drusen reduction, but does not seem to reduce the development of CNV. A case series and a study utiliz- ing subthreshold micropulse laser and nanosecond laser, respectively, in dry AMD patients have shown partial drusen regression but with no improve- ment in BCVA (Rykov et al. 2015). In contrast to laser treatment, PBM utilizes very low energy levels causing no tissue damage. Photobiomodulation stimulates cellular processes that pro- vide an approach to target the under- lying degenerative pathology with disease-modifying potential. A recent review paper of PBM in retinal diseases has reported that the literature sup- ports the conclusion that the low cost and non-invasive nature of PBM cou- pled with the first promising clinical reports and the numerous preclinical studies in animal models make PBM well poised to become an important player in the treatment of retinal dis- orders (Geneva 2016). A randomized control group was not included as these patients were being treated in an off-label protocol with commercial instruments that were limited in flexibility to modify or mask treatments. Consideration was given to using just one of the subjects’ eyes as a control; however, this was not accept- able to patients receiving the treatment and there is a possibility of systemic signalling and improvement in remote tissues with PBM. Therefore, it is most desirable to completely separate active patients from control in future studies. Examiner bias was mitigated by rigor- ously ensuring identical conditions at each visit for all patients with an experienced physician. Subgroup anal- ysis should be considered preliminary and intriguing as the subject numbers are limited; however, significant posi- tive conclusions can be drawn on the main end-points of ETDRS BCVA, CS and drusen reduction. The data presented have formed the basis for a National Eye Institute partially funded grant to support a Health Canada- and IRB-approved, randomized, placebo (sham treatment), double-masked prospective, clinical trial that is currently enrolling in Toronto. The LIGHTSITE I trial is looking at similar clinical and anatom- ical end-points that are presented here with the addition of microperimetry and VFQ-25. The present study demonstrated drusen reduction utilizing selected mul- tiple wavelengths of LED sourced light that are non-thermal and shown to have anti-inflammatory, antioxidative, neuroprotective and anti-apoptotic ben- efits as evident in several in vitro and in vivo ocular models (Eells et al. 2003; Albarracin et al. 2011; Tang et al. 2013; Gkotsi et al. 2014). It is the com- bination of anatomical changes coinci- dent with functional improvements that is most promising for PBM as a novel treatment for dry AMD. The clinical results to date provide the foundation for a novel non-invasive approach to the treatment of dry AMD. References Albarracin R, Eells J & Valter K (2011): Photobiomodulation protects the retina from light-induced photoreceptor degenera- tion. Invest Ophthalmol Vis Sci 52: 3582– 3592. Alten F & Eter N (2015): Current knowledge on reticular pseudodrusen in age-related macular degeneration. Br J Ophthalmol 99: 717–722. Beck RW, Moke PS, Turpin AH et al. (2003): A computerized method of visual acuity testing: adaptation of the early treatment of diabetic retinopathy study testing protocol. Am J Ophthalmol 135: 194–205. Chowers I, Tiosano L, Audo I, Grunin M & Boon CJ (2015): Adult-onset foveomacular vitelliform dystrophy: a fresh perspective. Prog Retin Eye Res 47: 64–85. Ctori I & Huntjens B (2015): Repeatabil- ity of foveal measurements using spec- tralis optical coherence tomography segmentation software. PLoS One 10: e0129005. Davis MD, Gangnon RE, Lee LY et al. (2005): The age-related eye disease study severity scale for age-related macular degen- eration: AREDS report no. 17. Arch Oph- thalmol 123: 1484–1498. Eells JT, Henry MM, Summerfelt P, Wong- Riley MT, Buchmann EV, Kane M, Whelan NT & Whelan HT (2003): Therapeutic photobiomodulation for methanol-induced retinal toxicity. Proc Natl Acad Sci U S A 100: 3439–3444. Elliott DB & Sheridan M (1988): The use of accurate visual acuity measurements in clin- ical anti-cataract formulation trials. Oph- thalmic Physiol Opt 8: 397–401. e276PDF Image | Photobiomodulation reduces drusen in macular degeneration
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