Real World Data Comparison of Standard Care vs SDM Laser Vision Protection Therapy for Prevention of Neovascular AMD

References

• Wan LW, Xinyi S, Xiang L, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systemic review and meta-analysis. Lancet Glob Health. 2014;2(2). doi:10.1016/S2214-109X(13)70145-1
   Web of Science ®Google Scholar
• Ferris FL III, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthalmol. 1984;102(11):1640–1642. doi:10.1001/archopht.1984.01040031330019
   PubMed Web of Science ®Google Scholar
• Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report number 8. Arch Ophthalmol. 2001;119(10):1417–1436. doi:10.1001/archopht.119.10.1417
   PubMed Web of Science ®Google Scholar
• American Academy of Ophthalmology preferred practice pattern – update; 2015. Available from: https://www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp-2015. Accessed May 15, 2020.
   Google Scholar
• Luttrull JK, Chang DB, Margolis BWL, Dorin G, Luttrull DK. Laser re-sensitization of medically unresponsive neovascular age-related macular degeneration: efficacy and implications. Retina. 2015;35(6):1184–1194. doi:10.1097/IAE.0000000000000458
   PubMed Web of Science ®Google Scholar
• Luttrull JK, Margolis BWL. Functionally guided retinal protective therapy as prophylaxis for age-related and inherited retinal degenerations. A pilot study. Invest Ophthalmol Vis Sci. 2016;7(1):265–275. doi:10.1167/iovs.15-18163
   Web of Science ®Google Scholar
• Luttrull JK, Sinclair SH, Elmann S, Glaser BM. Low incidence of choroidal neovascularization following subthreshold diode micropulse laser (SDM) for high-risk AMD. PLoS One. 2018;13(8):e0202097. doi:10.1371/journal.pone.0202097
   PubMed Web of Science ®Google Scholar
• Luttrull JK, Sinclair SH, Elmann S, Chang DB, Kent D. Slowed progression of age-related geographic atrophy following subthreshold laser. Clin Ophthalmol. 2020;14:2983–2993. doi:10.2147/OPTH.S268322
   PubMed Web of Science ®Google Scholar
• Luttrull JK, Kent D. Modern retinal laser for neuroprotection in open-angle glaucoma. Samples JR, Ahmed IIK, editors. New Concepts in Glaucoma Surgery. Amsterdam: Kugler Publications; Sept 2019: 1.
   Google Scholar
• Luttrull JK. Low-intensity/high-density subthreshold diode micropulse laser (SDM) for central serous chorioretinopathy. Retina. 2016;36(9):1658–1663. doi:10.1097/IAE.0000000000001005
   PubMed Web of Science ®Google Scholar
• Luttrull JK. Improved retinal and visual function following subthreshold diode micropulse laser (SDM) for retinitis pigmentosa. Eye. 2018;32(6):1099–1110. doi:10.1038/s41433-018-0017-3
   PubMed Web of Science ®Google Scholar
• Luttrull JK, Samples JR, Kent D, Lum BJ. Panmacular subthreshold diode micropulse laser (SDM) as neuroprotective therapy in primary open-angle glaucoma. Glaucoma Res. 2018;2020:281–294.
   Google Scholar
• Luttrull JK, Musch MC, Mainster MA. Subthreshold diode micropulse photocoagulation for the treatment of clinically significant diabetic macular edema. Br J Ophthalmol. 2005;89(1):74–80. doi:10.1136/bjo.2004.051540
   PubMed Web of Science ®Google Scholar
• Luttrull JK, Kent D. Laser therapy to prevent choroidal neovascularization. In: Choroidal Neovascularization. Chhablanni J, editor. Springer Verlag; 2020. doi:10.1007/978-981-15-2213-0_30
   Google Scholar
• Luttrull JK, Spink CJ, Musch DA. Subthreshold diode micropulse panretinal photocoagulation for proliferative diabetic retinopathy. Eye. 2008;22(5):607–612. doi:10.1038/sj.eye.6702725
   PubMed Web of Science ®Google Scholar
• Luttrull JK, Dorin G. Subthreshold diode micropulse photocoagulation as invisible retinal phototherapy for diabetic macular edema.A review. Curr Diabetes Rev. 2012;8(4):274–284. doi:10.2174/157339912800840523
   PubMedGoogle Scholar
• Kozak I, Luttrull JK. Modern retinal laser therapy. Saudi J Ophthalmol. 2015;29(2):137–146. doi:10.1016/j.sjopt.2014.09.001
   PubMed Web of Science ®Google Scholar
• Luttrull JK, Sramek C, Palanker D, Spink CJ, Musch DC. Long-term safety, high-resolution imaging, and tissue temperature modeling of subvisible diode micropulse photocoagulation for retinovascular macular edema. Retina. 2012;32(2):375–386. doi:10.1097/IAE.0b013e3182206f6c
   PubMed Web of Science ®Google Scholar
• Luttrull JK, Sinclair SD. Safety of transfoveal subthreshold diode micropulse laser for intra-foveal diabetic macular edema in eyes with good visual acuity. Retina. 2014;34(10):2010–2020. doi:10.1097/IAE.0000000000000177
   PubMed Web of Science ®Google Scholar
• Chang DB, Luttrull JK. Comparison of subthreshold 577nm and 810nm micropulse laser effects on heat-shock protein activation kinetics: implications for treatment efficacy and safety. Transl Vis Sci Technol. 2020;9(5):23. doi:10.1167/tvst.9.5.23
   PubMed Web of Science ®Google Scholar
• Keunen JEE, Battaglia-Parodi M, Vujosevic S, Luttrull JK. International retinal laser society guidelines for subthreshold laser treatment. Transl Vis Sci Technol. 2020;9(9):15. doi:10.1167/tvst.9.9.15
   PubMed Web of Science ®Google Scholar
• Lavinsky D, Cardillo JA, Melo LA Jr., et al. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011;52(7):4314–4323. doi:10.1167/iovs.10-6828
   PubMed Web of Science ®Google Scholar
• Chen G, Tzekov R, Li W, et al. Subthreshold micropulse diode laser versus conventional laser photocoagulation for diabetic macular edema. A meta-analysis of randomized controlled trials. Retina. 2016;36(11):2059–2065. doi:10.1097/IAE.0000000000001053
   PubMed Web of Science ®Google Scholar
• Chhablani J, Roh YJ, Jobling AI, et al. Restorative retinal laser therapy: present state and future directions. Surv Ophthalmol. 2018;63(3):307–328. doi:10.1016/j.survophthal.2017.09.008
   PubMed Web of Science ®Google Scholar
• Kim SC, Schneeweiss S. When randomized clinical trials and real-world evidence say the same: tocilizumab and its cardiovascular safety. Arthritis Rheumatol. 2019. doi:10.1002/art.41092
   Web of Science ®Google Scholar
• Jupiter DC. Propensity score matching: retrospective randomization? J Foot Ankle Surg. 2017;56(2):417–420. doi:10.1053/j.jfas.2017.01.013
   PubMed Web of Science ®Google Scholar
• Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika. 1983;70(1):41–55. doi:10.1093/biomet/70.1.41
   Web of Science ®Google Scholar
• Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46(3):399–424. doi:10.1080/00273171.2011.568786
   PubMed Web of Science ®Google Scholar
• Greenhouse JB. Commentary: cornfield, epidemiology and causality. Int J Epidemiol. 2009;38(5):1199–1201. doi:10.1093/ije/dyp299.
   PubMed Web of Science ®Google Scholar
• Gregori NZ, Feuer W, Rosenfeld PJ. Novel method for analyzing Snellen visual acuity measurements. Retina. 2010;30(7):1046–1050. doi:10.1097/IAE.0b013e3181d87e04
   PubMed Web of Science ®Google Scholar
• Wang RY, Strong DM. Beyond accuracy: what data quality means to data consumers. J Manag Inf Syst. 1996;12(4):5–53.
   Google Scholar
• Sheehan JG. Fraud, conflict of interest, and other enforcement issues in clinical research. Cleve Clin J Med. 2007;74(Suppl 2):S63–9. doi:10.3949/ccjm.74.suppl_2.s63
   PubMedGoogle Scholar
• Guymer RH, Wu Z, Hodgson LAB; Laser Intervention in Early Stages of Age-Related Macular Degeneration Study Group, et al. Subthreshold nanosecond laser intervention for age-related macular degeneration: the LEAD randomized controlled clinical trial. Ophthalmology. 2018. doi:10.1016/j.ophtha.2018.09.015
   Web of Science ®Google Scholar
• Frizziero L, Calciati A, Midena G, et al. Subthreshold micropulse laser modulates retinal neuroinflammatory biomarkers in diabetic macular edema. J Clin Med. 2021;10(14):3134. PMID:34300297. doi:10.3390/jcm10143134
   PubMed Web of Science ®Google Scholar
• Inagaki K, Shuo T, Katakura K, Ebihara N, Murakami A, Ohkoshi K. Sublethal photothermal stimulation with a micropulse laser induces heat shock protein expression in ARPE-19 Cells. J Ophthalmol. 2015;729792:2015.
   Google Scholar
• Midena E, Bini S, Martini F, et al. Changes of aqueous humor Muller cells’ biomarkers in human patients affected by diabetic macular edema after subthreshold micropulse laser treatment. Retina. 2018. doi:10.1097/IAE.0000000000002356
   Web of Science ®Google Scholar
• Iwami H, Pruessner J, Shariaki K, Brinkmann R, Miura Y. Protective effect of a laser-induced sub-lethal temperature rise on RPE cells from oxidative stress. Exp Eye Res. 2014;124:37–47. doi:10.1016/j.exer.2014.04.014
   PubMed Web of Science ®Google Scholar
• Hattenbach LO, Beck KF, Pfeilschifter J, Koch F, Ohrloff C, Schake W. Pigment epithelium- derived factor is up regulated in photocoagulated human retinal pigment epithelial cells. Ophthalmic Res. 2005;37(6):341–346. doi:10.1159/000088263
   PubMed Web of Science ®Google Scholar
• Caballero S, Kent DL, Sengupta N, et al. Bone marrow-derived cell recruitment to the neurosensory retina and retinal pigment epithelial cell layer following subthreshold retinal phototherapy. Invest Ophthalmol Vis Sci. 2017;58(12):5164–5176. doi:10.1167/iovs.16-20736
   PubMed Web of Science ®Google Scholar
• De Cilla S, Vezzola D, Farruggio S, et al. The subthreshold micropulse laser treatment of the retina restores the oxidant/antioxidant balance and counteracts programmed forms of cell death in the mice eyes. Acta Ophthalmol. 2018;97(4):e559–e567. doi:10.1111/aos.13995
   PubMed Web of Science ®Google Scholar
• Flaxel C, Bradle J, Acott T, Samples JR. Retinal pigment epithelium produces matrix metalloproteinases after laser treatment. Retina. 2007;27(5):629–634. doi:10.1097/01.iae.0000249561.02567.fd
   PubMed Web of Science ®Google Scholar
• Ciulla TA, Huang F, Westby K, et al. Real-world outcomes of anti-vascular endothelial growth factor therapy in neovascular age-related macular degeneration in the United States. Ophthalmol Retina. 2018;2(7):645–653. doi:10.1016/j.oret.2018.01.006
   PubMedGoogle Scholar
• Ciulla TA, Hussain RM, Pollack JS, Williams DF. Visual acuity outcomes and anti-vascular endothelial growth factor therapy intensity in neovascular age-related macular degeneration patients. A real-world analysis of 49, 485 eyes. Ophthalmol Retina. 2019;4(1):19–30. doi:10.1016/j.oret.2019.05.017
   PubMedGoogle Scholar
• Enríquez AB, Baumal CR, Crane AM, et al. Early experience with brolucizumab treatment of neovascular age-related macular degeneration. JAMA Ophthalmol. 2021;139(4):441–448. PMID: 33630045; PMCID: PMC7907988. doi:10.1001/jamaophthalmol.2020.7085
   PubMed Web of Science ®Google Scholar
• Schilsky RL. Finding the evidence in real-world evidence: moving from data to information to knowledge. JACS. 2017;224(1):1–7.
   Google Scholar
• Anglemyer A, Horvath HT, Bero L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev. 2014;2014(4). doi:10.1002/14651858.MR000034.pub2
   PubMed Web of Science ®Google Scholar
• Chalmers TC, Celano P, Sacks HS, Smith H. Bias in treatment assignment in controlled clinical trials Review. New Eng J Med. 1983;309(22):1358–1361. doi:10.1056/NEJM198312013092204
   PubMed Web of Science ®Google Scholar
• Bhandari M, Busse JW, Jackowski D, et al. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ. 2004;170(4):477–480.
   PubMed Web of Science ®Google Scholar
• Solomon SD, Lindsley K, Vedula SS, Ksystolik MG, Hawkins BS. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2019;4(3):CD005139. doi:10.1002/14651858.CD005139.pub4
   Web of Science ®Google Scholar
• Mitchell P, Annemans L, White R, et al. Cost effectiveness of treatments for wet age-related macular degeneration. Pharmacoeconomics. 2011;29(2):107–131. doi:10.2165/11585520-000000000-00000
   PubMed Web of Science ®Google Scholar
• Rosenfeld PJ, Feuer WJ. Warning: do not treat intermediate AMD with laser therapy. Am J Ophthalmol. 2019;125(6):839–840.
   Google Scholar