Összefoglaló. Bevezetés és célkitűzés: A Navilas® 577s mikropulzuslézerrel végzett kezelés biztonságosságának és hatásosságának vizsgálata diabeteses maculaoedemában. Módszer: Retrospektív vizsgálatunkba diabeteses maculaoedema miatt gondozott és legalább 6 hónapos utánkövetéssel rendelkező, korábban Navilas® 577s mikropulzuslézer-kezelésen átesett 28 beteg 46 szemét válogattuk be. Minden szemen optikaikoherencia-tomográfia (OCT) vastagsági térkép navigált, nonkontakt, küszöb alatti mikropulzuslézer-kezelés történt egy alkalommal. A kezelést megelőzően és az azt követő 6. hónapban rögzítettük a látóélesség, a centrális retinavastagság értékeit és az éreredetű endothelialis növekedési faktort (VEGF) gátló injekciók számát. A követési idő végén megvizsgáltuk a szemfenéki képnek a digitális fundusfotográfia és az átmetszeti OCT-képek segítségével észlelhető változásait. Eredmények: A vizsgált szemek közül 30 esetben a lézerkezelést korábbi centrális maculaoedema miatt VEGF-gátló injekciós kezelés előzte meg, míg 16 szem esetében primer lézerkezelés történt. A Navilas® 577s mikropulzuslézer-kezelést követően 6 hónappal sem a látóélesség, sem a centrális maculavastagság nem változott szignifikánsan egyik csoportban sem (p>0,05). Ugyanakkor a korábban injekciós kezelésben részesült szemek esetében a lézerkezelést megelőző 6 hónapban adott injekciók száma az átlagos 2,63 ± 1,18 értékről átlagosan 0,5 ± 0,73 értékre csökkent (p<0,001). A fundusfotókon és az átmetszeti OCT-scaneken a lézerkezelést követően egyetlen szem esetében sem találtunk látható pigmentelváltozásokat vagy hegesedést. Következetetés: Megfigyeléseink szerint a Navilas® 577s mikropulzuslézer-kezelés biztonságos a diabeteses maculaoedemás betegek kezelésében, továbbá a VEGF-gátlóval kezelt szemeken szerepet játszhat az injekciók számának csökkentésében. Orv Hetil. 2020; 161(49): 2078–2085.
Summary. Introduction and objective: To assess the safety and efficacy of Navilas® 577s micropulse subthreshold laser in the treatment of non-center involved diabetic macular edema. Method: In this retrospective study, we included 46 eyes of 28 patients with diabetic macular edema, who were treated at least 6 months ago with Navilas® 577s micropulse laser. Laser treatment was navigated by optical coherence tomography (OCT) macular thickness map in subthreshold micropulse mode at one occasion. Data from visual acuity testing, retinal thickness, and the number of anti-vascular endothelial growth factor (VEGF) injections needed 6 months before and after treatment were registered. At the end of the follow-up, digital fundus photography and OCT radial scans were performed to evaluate any possible anatomical changes. Results: 30 eyes had previous anti-VEGF treatment for central macular edema, and in 16 eyes we performed the laser as primary treatment. At the end of the follow-up, no significant visual acuity or central retinal thickness change were observed (p>0.05). On the other hand, in the anti-VEGF pretreated group the number of injections decreased significantly from 2.63 ± 1.18 to 0.5 ± 0.73 (p<0.001). We did not find any pigmentary changes or visible signs of scaring on final fundus photography pictures or OCT radial scans. Conclusion: Navilas® 577s subthreshold microsecond laser proved to be a safe option in the treatment of diabetic macular edema. It can be very useful in anti-VEGF treated eyes by decreasing the number of injections needed. Orv Hetil. 2020; 161(49): 2078–2085.
Tóth G, Szabó D, Sándor GL, et al. Diabetes and diabetic retinopathy in people aged 50 years and older in Hungary. Br J Ophthalmol. 2017; 101: 965–969.
Simon K, Dobó E, Szépvölgyi A, et al. Questions in diabetology to be elucidated. [Diabetológiai kérdőjelek.] Orv Hetil. 2011; 152: 1353–1361. [Hungarian]
Williams R, Airey M, Baxter H, et al. Epidemiology of diabetic retinopathy and macular oedema: a systematic review. Eye (Lond). 2004; 18: 963–983.
Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study Research Group. Arch Ophthalmol. 1985; 103: 1796–1806.
Schatz H, Madeira D, McDonald HR, et al. Progressive enlargement of laser scars following grid laser photocoagulation for diffuse diabetic macular edema. Arch Ophthalmol. 1991; 109: 1549–1551.
Lewis H, Schachat AP, Haimann MH, et al. Choroidal neovascularization after laser photocoagulation for diabetic macular edema. Ophthalmology 1990; 97: 503–510; discussion 510–511.
Guyer DR, D’Amico DJ, Smith CW. Subretinal fibrosis after laser photocoagulation for diabetic macular edema. Am J Ophthalmol. 1992; 113: 652–656.
Rutledge BK, Wallow IH, Poulsen GL. Sub-pigment epithelial membranes after photocoagulation for diabetic macular edema. Arch Ophthalmol. 1993; 111: 608–613.
Mitchell P, Bandello F, Schmidt-Erfurth U, et al., RESTORE Stud Group. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology 2011; 118: 615–625.
Nguyen QD, Shah SM, Khwaja AA, et al., READ-2 Study Group. Two-year outcomes of the Ranibizumab for Edema of the Macula in Diabetes (READ-2) study. Ophthalmology 2010; 117: 2146–2151. [Erratum: Ophthalmology 2011; 118: 1016.]
Elman MJ, Aiello LP, Beck RW, et al., Diabetic Retinopathy Clinical Research Network. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2010; 117: 1064–1077.e35.
Do DV, Nguyen QD, Khwaja AA, et al., READ-2 Study Group. Ranibizumab for edema of the macula in diabetes study: 3-year outcomes and the need for prolonged frequent treatment. JAMA Ophthalmol. 2013; 131: 139–145.
Massin P, Bandello F, Garweg JG, et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care 2010; 33: 2399–2405.
Nguyen QD, Brown DM, Marcus DM, et al., RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 2012; 119: 789–801.
Brynskov T, Laugesen CS, Sørensen TL. Intravitreal ranibizumab for diabetic macular oedema: 1-year experiences in a clinical setting. Acta Ophthalmol. 2013; 91: e243–e244.
Mainster MA. Decreasing retinal photocoagulation damage: principles and techniques. Semin Ophthalmol. 1999; 14: 200–209.
Friberg TR, Karatza EC. The treatment of macular disease using a micropulsed and continuous wave 810-nm diode laser. Ophthalmology 1997; 104: 2030–2038.
Vujosevic S, Bottega E, Casciano M, et al. Microperimetry and fundus autofluorescence in diabetic macular edema: subthreshold micropulse diode laser versus modified Early Treatment Diabetic Retinopathy Study laser photocoagulation. Retina 2010; 30: 908–916.
Ohkoshi K, Yamaguchi T. Subthreshold micropulse diode laser photocoagulation for diabetic macular edema in Japanese patients. Am J Ophthalmol. 2010; 149: 133–139.
Kernt M, Cheuteu RE, Cserhati S, et al. Pain and accuracy of focal laser treatment for diabetic macular edema using a retinal navigated laser (Navilas). Clin Ophthalmol. 2012; 6: 289–296.
Legarreta JE, Gregori G, Punjabi OS, et al. Macular thickness measurements in normal eyes using spectral domain optical coherence tomography. Ophthalmic Surg Lasers Imaging 2008; 39: S43–S49.
Schneider M, Szekeres O, Kiss H, et al. Comparison of thickness values in nine macular subfields using time-domain and spectral-domain optical coherence tomography. [Vastagságértékek összehasonlítása kilenc macularis mezőben time-domain és spectral-domain optikai koherencia tomográfiával.] Orv Hetil. 2013; 154: 2059–2064. [Hungarian]
Fassbender B. Treatment considerations of the Navilas laser system. OD-OS GmbH | Le document version 1.9 OD-OS GmBH 2019; 1/1
Fazel F, Bagheri M, Golabchi K, et al. Comparison of subthreshold diode laser micropulse therapy versus conventional photocoagulation laser therapy as primary treatment of diabetic macular edema. J Curr Ophthalmol. 2016; 28: 206–211.
Inagaki K, Ohkoshi K, Ohde S, et al. Comparative efficacy of pure yellow (577-nm) and 810-nm subthreshold micropulse laser photocoagulation combined with yellow (561–577-nm) direct photocoagulation for diabetic macular edema. Jpn J Ophthalmol. 2015; 59: 21–28.
Vujosevic S, Martini F, Longhin E, et al. Subthreshold micropulse yellow laser versus subthreshold micropulse infrared laser in center-involving diabetic macular edema: morphologic and functional safety. Retina 2015; 35: 1594–1603.
Othman IS, Eissa SA, Kotb MS, et al. Subthreshold diode-laser micropulse photocoagulation as a primary and secondary line of treatment in management of diabetic macular edema. Clin Ophthalmol. 2014; 8: 653–659.
Venkatesh P, Ramanjulu R, Azad R, et al. Subthreshold micropulse diode laser and double frequency neodymium: YAG laser in treatment of diabetic macular edema: a prospective, randomized study using multifocal electroretinography. Photomed Laser Surg. 2011; 29: 727–733.
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: 4314–4323.
Nakamura Y, Mitamura Y, Ogata K, et al. Functional and morphological changes of macula after subthreshold micropulse diode laser photocoagulation for diabetic macular oedema. Eye (Lond). 2010; 24: 784–788.
Figueira J, Khan J, Nunes S, et al. Prospective randomised controlled trial comparing sub-threshold micropulse diode laser photocoagulation and conventional green laser for clinically significant diabetic macular oedema. Br J Ophthalmol. 2009; 93: 1341–1344.
Laursen M, Moeller F, Sander B, et al. Subthreshold micropulse diode laser treatment in diabetic macular oedema. Br J Ophthalmol. 2004; 88: 1173–1179.
Liegl R, Langer J, Seidensticker F, et al. Comparative evaluation of combined navigated laser photocoagulation and intravitreal ranibizumab in the treatment of diabetic macular edema. PLoS ONE 2014; 9: e113981.
Herold TR, Langer J, Vounotrypidis E, et al. 3-year-data of combined navigated laser photocoagulation (Navilas) and intravitreal ranibizumab compared to ranibizumab monotherapy in DME patients. PLoS ONE 2018; 13: e0202483.
Lois N, Gardner E, Waugh N, et al., DIAMONDS Study Group. Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial. Trials 2019; 20: 122.
Kozak I, Oster SF, Cortes MA, et al. Clinical evaluation and treatment accuracy in diabetic macular edema using navigated laser photocoagulator NAVILAS. Ophthalmology 2011; 118: 1119–1124.
Schechet SA, Adams OE, Eichenbaum DA, et al. Macular thickness amplitude changes when switching from discontinuous to continuous therapy for diabetic macular oedema. BMJ Open Ophthalmol. 2019; 4: e000271.