この短いビデオインタビューで、Jacob Menzler医師は、抗VEGF単剤療法とNavilasの使用および注射回数の減少を比較した研究について解説しています。本研究の著者らは、ヨーロッパ4カ国および米国において、いずれかの治療法を用いた5年間の医師の収入を比較する経済モデルを構築しました。 同医師らは、患者のアドヒアランスが高いため、分析したすべての国において抗VEGFによるナビゲーションレーザ療法を使用する医師は、抗VEGF単剤療法と比較して同等以上の収益を生み出していると結論付けています。
Benefits of navigation for peripheral application
Comparison of Pain Scores Among Patients Undergoing Conventional and Novel Panretinal Photocoagulation for Diabetic Retinopathy: A Systematic Review. Azarcon, C. P., & Artiaga, J. C. M. (2021). Clinical Ophthalmology (Auckland, NZ), 15, 953. PubMed PMID: 33688163
Conclusion: "This review summarizes findings of multiple studies that reported pain as an adverse outcome of PRP among patients with advanced diabetic retinopathy. Data from RCTs with mostly some concerns for bias (RoB 2 tool) and CCTs with mostly moderate risk of bias (ROBINS-I tool) show benefit of using MSL over SSL, and NNL over conventional systems for PRP in diabetic retinopathy, considering pain as the primary outcome."
Safety and efficacy of the use of navigated retinal laser as a method of laser retinopexy in the treatment of symptomatic retinal tears. Somoskeoy, T., & Shah, P. (2020). Eye, 1-5. PubMed PMID: 32587386
Conclusion: "The use of navigated retinal laser as a method of laser retinopexy for the treatment of retinal tears shows comparable safety and efficacy with other studies using traditional retinal laser systems."
Retinal Vascular Oxygen Saturation in Response to a Less Extensive Laser Treatment in Proliferative Diabetic Retinopathy. Vergmann, Anna Stage, Thomas Lee Torp, Ryo Kawasaki, Danjal Hofgaard Hestoy, Tien Yin Wong, Tunde Peto, und Jakob Grauslund. Acta Ophthalmologica n/a, Nr. n/a (23. Dezember 2020). PubMed PMID: 33354935
Conclusion: "In this study of patients with treatment-naïve PDR, we showed that a less extensive laser treatment caused a reduction in retinal venular oxygen saturation and diameter 6 months after treatment. Our results suggest that less extensive laser treatment may be sufficient to improve the retinal metabolic environment conducive to PDR regression."
Efficacy and Side Effects of Individualized Panretinal Photocoagulation. Vergmann AS, Nguyen TT, Lee Torp T, et al. Ophthalmology Retina. 2020;4(6):642-644. doi:10.1016/j.oret.2020.02.006
PubMed PMID 32278741
Conclusion: "We conclude a less-intensive, individualized retinal photocoagulation, targeting only retinal quadrants with retinal neovascularization, has a similar efficacy as standard PRP in patients who are regularly seen in the clinics. In addition, limited side effects, balanced between groups, could indicate a gentler approach performed by the navigated laser system used in both treatment arms. This pilot study adds to the ongoing discussion of individualizing and balancing efficacy and side effects in PDR. Although VA loss was prevented at month 6 in our study, we cannot speculate to the long-term sustainability of results. Thus, upcoming randomized trials addressing long-term VA and treatment efficacy, and including additional relevant end points such as electroretinography would be important to confirm these findings."
[Preventive laser treatment of tractional symptomatic retinal flap tears: long-term outcomes]. Shaimova, V. A., T. B. Shaimov, E. V. Boiko, R. B. Shaimov, A. S. Zarezina, T. G. Kravchenko, A. Yu Galin, u. a.“. Vestnik Oftalmologii 136, Nr. 3 (2020): 32–38. PubMed PMID: 32504474
Conclusion: "Follow-up of tractional symptomatic flap tears for 5 years after preventive laser retinopexy revealed the appearance of retinal detachment in 2.5% of cases. Laser retinotomy of horseshoe tear after barrier retinopexy eliminated the traction component and helped prevent the development of RRD"
Comparison of Navigated Laser and Conventional Single-Spot Laser System for Induced Pain during Panretinal Photocoagulation. Polat, Onur, Sibel Inan, Zeki Baysal, Safiye Yigit, und Umit Ubeyt Inan. Lasers in Medical Science 35, Nr. 3 (April 2020): 687–93. PubMed PMID: 31741148
Conclusion: "In conclusion, Navilas is capable of producing more precise laser spots with lower energy levels and shorter pulse durations causing significant decrease in pain perception during laser photocoagulation and can increase the patient’s compliance with the laser treatment."
Comparison of pain experience and time required for pre-planned navigated peripheral laser versus conventional multispot laser in the treatment of diabetic retinopathy. Amoroso, F., Pedinielli, A., Astroz, P., Semoun, O., Capuano, V., Miere, A., & Souied, E. H. (2019). Acta diabetologica, 1-7. PubMed PMID: 31749047
Conclusion: "The PRP sessions using the Navilas laser were significantly faster and less painful than with a conventional multispot laser in our series."
Navigated Retina Laser Therapy as a Novel Method for Laser Retinopexy of Retinal Tears. Gologorsky, Daniel; Rosen, Richard B.; Giovinazzo, Jerome; Jansen, Michael; Landa, Gennady, Lee, Jessica. Ophthalmic Surgery, Lasers & Imaging Retina. April 2018. 49:e206-e209. PubMed PMID: 30457657
Conclusion: "In select cases, a navigated laser system may be utilized for the treatment of retinal tears."
Navigated Pattern Laser System versus Single-Spot Laser System for Postoperative 360-Degree Laser Retinopexy. Kulikov, Alexei N., Dmitrii S. Maltsev, and Ernest V. Boiko. Journal of Ophthalmology (2016). PubMed PMID: 28070417
Conclusion. "The navigated pattern approach allows improving the treatment time and pain in postoperative 360° LRP. Moreover, 360° pattern LRP is at least as effective in achieving the surgical goal as the conventional (slit-lamp or indirect ophthalmoscope) approaches with a single-spot laser."
Comparison of Pain Scores between Patients Undergoing Panretinal Photocoagulation Using Navigated or Pattern Scan Laser Systems. Inan, Umit Ubeyt, Onur Polat, Sibel Inan, Safiye Yigit, and Zeki Baysal. Arquivos Brasileiros de Oftalmologia 79, no. 1 (2016). PubMed PMID: 26840160
Conclusion: "Pain responses in patients undergoing PRP with a 30-ms pulse duration were significantly milder in the NAVILAS group than in the PASCAL group."
Targeted Photocoagulation of Peripheral Ischemia to Treat Rebound Edema. Singer, Michael, Krishna Surapaneni, Srinivas Sadda, and Colin Tan. Clinical Ophthalmology, February 2015, 337. PubMed PMID: 25709396
Conclusion: "In this study, we demonstrate the use of widefield imaging with targeted photo-coagulation of peripheral ischemia to treat rebound edema, while preserving most peripheral vision. In order to treat rebound edema, extensive TRP, across reversible and nonreversible areas of ischemia, had to be performed - not just in areas of nonreversible peripheral ischemia. These areas need to be mapped during episodes of rebound edema, when ischemia is at its maximum. In this way, by doing the most TRP possible, the cycle of rebound edema can be broken."
Panretinal Navigated Laser Photocoagulation for PDR. Lin, K., and S. Lu. Retina Today, 2014, 65-70. link
Conclusion: "This study reports the first clinical experience with the Navilas panretinal photocoagulator. It delivers safe and fast treatments that are comfortable for the physician and the patient."
Comparison of Conventional Pattern and Novel Navigated Panretinal Photocoagulation in Proliferative Diabetic Retinopathy. Chhablani, Jay, Annie Mathai, Padmaja Rani, Vishali Gupta, J. Fernando Arevalo, and Igor Kozak. Investigative Opthalmology & Visual Science 55, no. 6 (June 4, 2014): 3432. PubMed PMID: 24787564
Conclusion: "Navigated laser treatment achieves more uniform laser burns with less pain during shorter treatment duration in comparison with conventional pattern laser."
Benefits of navigation for threshold focal application
Selective Photocoagulation of Capillary Macroaneurysms by Navigated Focal Laser. Amoroso, F., Pedinielli, A., Colantuono, D., Jung, C., Capuano, V., Souied, E. H., & Miere, A. (2021). Ophthalmic Surgery, Lasers and Imaging Retina, 52(7), 366-373. Pubmed PMID: 34309425
Conclusion: "Solitary or secondary CMAs arising from retinal capillaries are candidates for navigated laser treatment. Navigated focal treatment was able to close all CMAs in this series with an improvement in vision and CMT."
Perifoveal exudative vascular anomalous complex treated with navigated retina laser. Journal Francais D'ophtalmologie. Remolí-Sargues, L., Montero-Hernández, J., & Cervera-Taulet, E. (2021). PubMed PMID: 34340884
Conclusion: "We presented a case of PEVAC treated with combined intravitreal injections of ranibizumab and focal Navilas®. For the best of our knowledge, the management of our case with focal Navilas® demonstrated good anatomical and functional results. Therefore, Navilas® may be an effective and safe treatment in PEVAC, but further studies are needed to confirm the use of Navilas® as the first therapeutic option."
OCTA-Guided Navigated Laser Therapy for Advanced Macula Neovascularization Secondary to Age Related Macular Degeneration. Amoroso, Francesca, Eric H Souied, Salomon Yves Cohen, Alexandre Pedinielli, Polina Astroz, Rocio Blanco Garavito, Vittorio Capuano, Giuseppe Querques, und Alexandra Miere. European Journal of Ophthalmology, 22. Dezember 2020, 1120672120983191.
PubMed PMID: 3335340
Conclusion: "This preliminary study showed that Navilas treatment guided by OCTA may represent an attractive therapeutic option in advanced neovascular lesions secondary to AMD."
Efficacy of navigated focal laser photocoagulation in diabetic macular edema planned with en face optical coherence tomography versus fluorescein angiography. Maltsev, D. S., Kulikov, A. N., Burnasheva, M. A., Kazak, A. A., & Chhablani, J. (2020). International Ophthalmology, 1-9. PubMed PMID: 32285237
Conclusion: "En face OCT is a non-inferior alternative for FA in the planning of navigated FLP of microaneurysms in DME."
Information Technology for Decision-Making Support for Personalized Parameter Selection in Retinal Laser Treatment and Photocoagulation Outcome Prognostication. Ilyasova, N. Yu., A. S. Shirokanev, N. S. Demin, R. A. Paringer, und E. A. Zamytskiy. Optical Memory and Neural Networks 29, Nr. 4 (1. Oktober 2020): 358–67. https://doi.org/10.3103/S1060992X20040098.
Summary: "The technology developed will offer the retina specialist a preliminary photocoagulation plan, as well as allowing the assessment of the diabetic retinopathy treatment efficacy to be carried out."
Management of Coats Disease Microaneurysms With Fundus Fluorescein Angiography-Guided Navigated Laser. Brown, D., Kozak, I., Lampen, S. I., & Chhablani, J. (2019). Journal of VitreoRetinal Diseases, 3(1), 36-41. pdf on ResearchGate
Conclusion: "In this study, angiography-guided navigated laser treatment was a safe and effective treatment modality for Coats disease. The digital planning and navigated application of the laser seem to allow for good efficacy and a low complication rate."
Clinical application of fluorescein angiography-free navigated focal laser photocoagulation in central serous chorioretinopathy. Maltsev, D. S., Kulikov, A. N., & Chhablani, J. (2019). Ophthalmic Surgery, Lasers and Imaging Retina, 50(4), e118-e124. PubMed PMID: 30998255
Conclusion: "FA-free, OCT-guided navigated FLP is an effective and safe option to treat a significant number of patients with CSC."
Indocyanine green angiography-guided focal navigated laser photocoagulation for diabetic macular edema. Nozaki, M., Kato, A., Yasukawa, T., Suzuki, K., Yoshida, M., & Ogura, Y. (2019). Japanese journal of ophthalmology, 1-12. PubMed PMID: 30806869
Conclusion: "Our data suggest ICGA-guided navigated focal laser photocoagulation may be effective for the treatment of DME."
Direct navigated laser photocoagulation as primary treatment for retinal arterial macroaneurysms. Maltsev, Dmitrii S.; Kulikov, Alexei N.; Uplanchiwar, Bhushan; Lima, Luiz H.; Chhablani, Jay.. Int J Retin Vitr (2018) 4:28 PubMed PMID: 30151240
Conclusion: "This study demonstrated superiority of navigated laser photocoagulation compared to conventional laser photocoagulation in primary treatment of RAM which results from similar efficacy and safety of both techniques with lower mean total laser energy and number of laser burns required for navigated laser photocoagulation."
Navigated laser photocoagulation in patients with non-resolving and chronic central serous chorioretinopathy. Müller, B., Tatsios, J., Klonner, J., Pilger, D., & Joussen, A. M. (2018). Graefe's Archive for Clinical and Experimental Ophthalmology, 1-8. PubMed PMID: 29876733
Conclusion: "Laser treatment with Navilas® using eye tracking and FA-based planning is a safe and effective alternative therapy in patients with chronic CSCR."
Evaluation of Navigated Laser Photocoagulation (Navilas 577+) for the Treatment of Refractory Diabetic Macular Edema. Kato, Fusae, Miho Nozaki, Aki Kato, Norio Hasegawa, Hiroshi Morita, Munenori Yoshida, and Yuichiro Ogura. 2018. Journal of Ophthalmology 2018: 1–7. PubMed PMID: 29854426
Conclusion: "Focal photocoagulation using Navilas 577+ showed to be effective in treating DME with improvement in macular edema on OCT over 6 months. Navilas 577+ was beneficial to perform navigated laser photocoagulation based on three modalities (ICGA, FA, and OCT angiography)."
Tackling challenges retina cases with laser therapy. Rajan Gupta, Jay Chhablani (2018). Retina Today 2018 Vol. 13, No 8 (page 24).
Summary: "In this article we describe three such cases, with symptoms related to age-related macular degeneration (AMD), in which we relied on the Navilas to individually preplan and tailor the application of laser treatments."
Treatment of macroaneurisms in macular oedema: Navigated laser leads the next generation of photocoagulation therapy. J. C. Ramel. Ophthalmology Times Dec. 2018 Vol 14. No 10. page 27
Conclusion: "Macular oedema is a disabling pathological accumulation of fluid in the macula and is common in developed countries among diabetic and aging patients. Current treatments with photocoagulation using the slit lamp are efficacious, but the Navilas endorses automated focusing and eye-tracking software that greatly enhance the precision and ease of treatment. In short, Navilas augments clinicians’ competence in treating patients by improving the safety, speed and precision of photocoagulation treatment."
Central Serous Chorioretinopathy Treated With Navigated Retinal Laser Photocoagulation: Visual Acuity and Retinal Sensitivity. Mastropasqua, Leonardo, Luca Di Antonio, Lisa Toto, Alessandra Mastropasqua, Angelo Di Iorio, and Paolo Carpineto. “Ophthalmic Surgery, Lasers and Imaging Retina 46, no. 3 (March 1, 2015): 349–54. PubMed PMID: 25856822
Conclusion: "Navigated retinal laser photocoagulation demonstrated safety and accuracy for the treatment of acute CSC. VA and retinal sensitivity evaluations showed a significant improvement associated with resolution of the subretinal fluid during follow-up."
Navigated Focal Laser Photocoagulation for Central Serous Chorioretinopathy. Chhablani, Jay, Padmaja Kumari Rani, Annie Mathai, Subhadra Jalali, and Igor Kozak. “Clinical Ophthalmology, August 2014, 1543. PubMed PMID: 25170248
Conclusion: "Navilas(®) without a contact lens achieved resolution of subretinal fluid with a single laser spot for each single leak and minimum iatrogenic damage."
Time Required for Navigated Macular Laser Photocoagulation Treatment with the Navilas®. Ober, Michael D., Marcus Kernt, Marco A. Cortes, and Igor Kozak. Graefe’s Archive for Clinical and Experimental Ophthalmology 251, no. 4 (April 2013): 1049–53. PubMed PMID: 22868445
Conclusion: "Navilas is a novel device providing a time efficient platform for evaluating FA images and performing threshold macular laser photocoagulation."
Navigated Macular Laser Decreases Retreatment Rate for Diabetic Macular Edema: A Comparison with Conventional Macular Laser. Kernt, Marcus, A Kampik, Neubauer, Langer, Wolf, Kozak, Seidensticker, Ulbig, and Freeman. “Clinical Ophthalmology, January 2013, 121. PubMed PMID: 23345966
Conclusion: "The short-term results of this pilot study suggest that navigated macular photocoagulation is an effective technique and could be considered as a valid alternative to conventional slit-lamp laser for DME when focal laser photocoagulation is indicated. The observed lower retreatment rates with navigated retinal laser therapy in the first 8 months suggest a more durable treatment effect."
Pain and Accuracy of Focal Laser Treatment for Diabetic Macular Edema Using a Retinal Navigated Laser (Navilas). Kernt, Marcus, Cheuteu, Cserhati, Seidensticker, Liegl, Lang, Christos Haritoglou, A Kampik, Ulbig, and Neubauer. Clinical Ophthalmology, February 2012, 289. PubMed PMID: 22393280
Conclusion: "Navigated laser effects could be visualized to a high percentage on post-treatment color images, and their location showed a high concordance to targeted areas. Patients reported that treatment-related pain following Navilas laser photocoagulation was significantly lower than pain following conventional laser treatment."
Clinical Evaluation and Treatment Accuracy in Diabetic Macular Edema Using Navigated Laser Photocoagulator NAVILAS. Kozak, Igor, Stephen F. Oster, Marco A. Cortes, Dennis Dowell, Kathrin Hartmann, Jae Suk Kim, and William R. Freeman. Ophthalmology 118, no. 6 (June 2011): 1119–24. PubMed PMID: 21269701
Conclusion: "Laser photocoagulation using the NAVILAS system is safe and achieves a higher rate of accuracy in photocoagulation treatments of diabetic retinopathy lesions than standard manual-technique laser treatment. Precise manual preplanning and positioning of the treatment sites by the surgeon is possible, allowing accurate and predictable photocoagulation of these lesions."
Combination of Navilas® with Anti-VEGF
Perifoveal exudative vascular anomalous complex treated with navigated retina laser. Remolí-Sargues L, Montero-Hernández J, Monferrer Adsuara C, Castro Navarro V, Cervera-Taulet E. Journal Français d’Ophtalmologie [Internet]. 2021 Jul 30 [cited 2021 Sep 6]; Read article
Conclusion: We presented a case of PEVAC treated with combined intravitreal injections of ranibizumab and focal Navilas®. For the best of our knowledge, the management of our case with focal Navilas® demonstrated good anatomical and functional results. Therefore, Navilas® may be an effective and safe treatment in PEVAC, but further studies are needed to confirm the use of Navilas® as the first therapeutic option.
Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema: TREX-DME 3-year results. Payne, J. F., Wykoff, C. C., Clark, W. L., Bruce, B. B., Boyer, D. S., & Brown, D. M. (2020). British Journal of Ophthalmology. PubMed PMID: 32303499
Background/aims: To evaluate the long-term effects of treat-and-extend dosing of ranibizumab with and without navigated focal laser for diabetic macular oedema (DME).
Conclusion: "The improvements achieved after 2 years of treat-and-extend ranibizumab for DME were maintained in the third year with a mean of 3 intravitreal injections."
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A summary of all three publications of the TREX trial can be found here: https://www.od-os.com/expertlibrary/the-role-of-navigated-laser-in-trex-dme/
(First experiences with Navilas® 577s micropulse laser in the treatment of diabetic maculopathy) Első tapasztalataink diabeteses maculopathia Navilas® 577s mikropulzuslézer-készülékkel történő kezelésével. Ecsedy, Mónika, Illés Kovács, Róbert Gergely, Katalin Gombos, Judit Meisel, Andrea Kovács, Cecilia Czakó, und Zoltán Zsolt Nagy. Orvosi Hetilap 161, Nr. 49 (6. Dezember 2020): 2078–85. https://doi.org/10.1556/650.2020.31935.
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."
Aflibercept and navigated versus conventional laser in diabetic macular oedema: a 12‐month randomized clinical trial. Blindbæk, S. L., Peto, T., & Grauslund, J. (2020). Acta Ophthalmologica, 98(4), 347-352. PubMed PMID: 31602811
Conclusion: "No difference in need for retreatment was detected between treatment arms of aflibercept and navigated versus conventional laser. Our results suggest that with proper timing of focal/grid laser photocoagulation combination therapy may reduce the need for intravitreal therapy during the first year of treatment."
Discussion: this study demonstrated a good functional outcome, with a remarkably low need for intravitreal aflibercept, in patients with centre-involved DME. Our results suggest that with proper timing of focal/grid laser photocoagulation combination therapy may reduce the need for intravitreal therapy during the first year of treatment.
Retinal arteriolar oxygen saturation predicts the need for intravitreal aflibercept in patients with diabetic macular oedema. Blindbæk SL, Peto T, Grauslund J. BMJ Open Ophthalmology. 2020;5(1):e000382. doi:10.1136/bmjophth-2019-000382 PubMed PMID 32524033
Conclusion: "Higher retinal arteriolar oxygen saturation independently predicted the need for more intravitreal aflibercept during the first year of DMO treatment and may serve as a valuable adjunctive to established procedures for retinal imaging in terms of individualized treatment plans."
Navigated laser in diabetic macular edema: the impact of reduced injection burden on patients and physicians-who wins and who loses?. Menzler J,Neubauer A,Ziemssen F., Int J Ophthalmol 2019;12(2):342-345,doi:10.18240/ijo.2019.02.24
Summary: "Due to patients’ higher therapy adherence, physicians using navigated laser therapy with anti-VEGF generate similar or higher revenues compared to VEGF monotherapy in all analyzed countries. The use of Navilas decreases the patient’s injection burden at the same clinical outcome, while the physician’s revenue remained stable or increased. Therewith, therapy discontinuation in DME can be reduced using the combination therapy with Navilas."
3-year-data of combined navigated laser photocoagulation (Navilas) and intravitreal ranibizumab compared to ranibizumab monotherapy in DME patients. Herold, T. R., Langer, J., Vounotrypidis, E., Kernt, M., Liegl, R., & Priglinger, S. G. (2018). PloS one, 13(8), e0202483. PubMed PMID: 30138384
Conclusion: "Combination of navigated laser and ranibizumab achieved BCVA gains equivalent to anti-VEGF monotherapy. These results could be maintained through month 36. Required injections were 2.0 injections lower in year 1 and further 1.3 times fewer in year 2 and 3 in the combination group compared to monotherapy. Adding navigated laser photocoagulation to intravitreal anti-VEGF therapy may still represent a superior therapeutic approach to DME patients."
From Art to Science in DME Treatment. ANG LI, BA, and RUMNEEK BEDI. “Accessed March 15, 2017. link
Conclusion: "There is a broad spectrum of types of DME, each of which demands a different mode of treatment, whether it is with anti-VEGF therapies, photocoagulation, or a combination of both. As physicians, our overall goals are to treat DME, to maintain our patients’ vision successfully, and to reduce the burden on our patients. In our hands, the OCT-based navigated laser approach has helped to improve outcomes and decrease treatment burden. Overall, it has enabled us to improve the accuracy and reproducibility of laser treatments, and it appears also to have improved retinal thickness outcomes to the level of anti-VEGF therapies (although further study is warranted). Perhaps most importantly, the navigated laser approach allows us to target microaneurysms precisely and effectively, while compensating for inadvertent eye movements and increases the likelihood that we will deliver the full laser treatment indicated for each patient. As with other technological advancements, navigated laser helps us standardize DME treatment, building on what had previously been more of an art, allowing more of us to deliver the results we aspire to achieve for our patients."
Combination of Navigated Macular Laser Photocoagulation and Anti-VEGF Therapy: Precise Treatment for Macular Edema under Dry Retinal Conditions. Boiko, Ernest V., and Dmitrii S. Maltsev. Journal of Ophthalmology 2017 (2017): 1–9. PubMed PMID: 28316837
Conclusion. "The controllability of navigated MLP in dry retina is improved compared to edematous retina. This study validates that pretreatment diagnostic images can be used as basis for navigated MLP after the edema has been resolved."
12-Month Results of the Standardised Combination Therapy for Diabetic Macular Oedema: Intravitreal Bevacizumab and Navigated Retinal Photocoagulation. Barteselli, Giulio, Igor Kozak, Sharif El-Emam, Jay Chhablani, Marco A Cortes, and William R Freeman. British Journal of Ophthalmology 98, no. 8 (August 2014): 1036–41. PubMed PMID: 24723616
Conclusion: "Standardized combination therapy using bevacizumab injections followed by navigated laser treatment for clinically significant diabetic macular oedema demonstrated significant visual gain and CRT reduction after bevacizumab treatment and stabilisation after navigated laser up to 12 months. The number of injections required in 12 months was lower than reported in previous combination studies."
Comparative Evaluation of Combined Navigated Laser Photocoagulation and Intravitreal Ranibizumab in the Treatment of Diabetic Macular Edema. Liegl, Raffael, Julian Langer, Florian Seidensticker, Lukas Reznicek, Christos Haritoglou, Michael W. Ulbig, Aljoscha S. Neubauer, Anselm Kampik, and Marcus Kernt. Edited by Demetrios Vavvas. PLoS ONE 9, no. 12 (December 26, 2014). PubMed PMID: 25541960
Conclusion: "Navigated laser combination therapy demonstrated significant visual gains in most patients. Retreatment rate and number of injections were significantly lower compared to ranibizumab monotherapy and compared to the results of conventional laser combination therapy previously reported in pivotal anti-VEGF studies."
NAVILAS Laser System Focal Laser Treatment for Diabetic Macular Edema-One Year Results of a Case Series. Jung, Jesse J., Roberto Gallego-Pinazo, Antonio Lleó-Pérez, Jonathan I. Huz, and Irene A. Barbazetto. The Open Ophthalmology Journal 7, no. 1 (2013). PubMed PMID: 24082979
Conclusion: Focal NAVILAS showed to be safe and effective in treating DME with improvement in visual acuity and macular edema on OCT over 12 months in this case series. In clinical practice, combined treatment with focal laser including NAVILAS and anti-vascular endothelial growth factor may provide long-term improvement in DME.
Navilas® in subthreshold applications
Navigated micropulse laser for central serous chorioretinopathy: Efficacy, safety, and predictive factors of treatment response. Amoroso, F., Pedinielli, A., Cohen, S. Y., Jung, C., Chhablani, J., Astroz, P., ... & Miere, A. (2021). European Journal of Ophthalmology, 11206721211064021. PubMed PMID: 34846180
Conclusion: "Navigated micropulse laser treatment was found to be effective and safe for the treatment of chorioretinopathy, with significant improvement in visual and anatomical outcomes, unaccompanied by any adverse event at 3 and 6 months follow-up. Factors associated to subretinal fluid resolution may allow a better selection of likely responders to navigated micropulse laser treatment."
Determination of Micropulse Modes with Targeted Damage to the Retinal Pigment Epithelium Using Computer Modeling for the Development of Selective Individual Micropulse Retinal Therapy. Ivanova, E. V., Volodin, P. L., & Guskov, A. V. (2021). Current Eye Research, 1-8. PubMed PMID: 34607475
Conclusion: "The concepts of efficiency and selectivity have been introduced to quantify the amount of damage caused. The optimal range of micropulse parameters which result in effective and selective damage on the RPE has been determined for the Navilas 577s laser system. The proposed method can be used for any other serial laser system. A comparison of the different micropulse modes, as well as the CW modes, has been performed."
Safety of various parameter sets with navigated microsecond pulsing laser in central serous chorioretinopathy. International Journal of Retina and Vitreous. Chhablani, J., Kalra, G., Alkwatli, L., Fassbender, B., Amoroso, F., Chandra, K., ... & Souied, E. (2021). 7(1), 1-7. PubMed PMID: 34656180
Conclusion: "In conclusion, none of the used parameter sets lead to tissue damage (when using a cautious titration) and, in summary, lead to an improvement in subretinal fluid and improvement in visual acuity. However, further prospective studies are needed to correctly identify the dependency of the treatment strategy on the outcome criteria."
Clinical Evaluation of Individualized and Navigated Microsecond Pulsing Laser for Acute Central Serous Chorioretinopathy. Pavel L. Volodin, MD, PhD; Elena V. Ivanova, MD, PhD. Ophthalmic Surgery, Lasers and Imaging Retina. 2020;51(9):512-520. Pubmed PMID: 32955591
Conclusion: "The parameter sets derived from the computer model can be applied safely and effectively for CSC treatment using the navigated microsecond pulsing laser system."
Article is related to: PubMed PMID: 34607475
The experience of using the Navilas® Laser System for micropulse laser exposure in patients with central serous choriopathy. Pomytkina, NV, IZ Kravchenko, und EL Sorokin. Modern technologies in ophtalmology, Nr. 1 (2020).
Conclusion: "1. SMLE, carried out using the Navilas navigation system, is an effective method for the treatment of CSH in case of its chronic course, as well as in the absence of the possibility of fluorescence angiography. 2. A complete regression of the detachment of neuroepithelium after SMLE exposure was achieved in 79% of patients with follow-up periods of 1 to 6 months. 3. The advantages of the Navilas navigation system are the formation of an individual patient treatment plan taking into account OCT data, visual monitoring of the implementation of the plan, as well as the possibility of non-contact laser treatment."
Micropulse laser therapy a safe treatment for retinal disorders. Di Carlo, E., Simni, C., Ophthalmology Times. July 2020. Read article
Conclusion: "Studies show that the micropulse laser represents a safe treatment for macular disorders involving the foveal area.
Regarding the efficacy, the results are not still uniform and for this reason we need further and larger studies to prove the real effectiveness related to all the macular pathologies.
In my opinion, we can currently consider the micropulse laser as an additional therapy, which may help physicians to treat disorders with complex pathophysiology, such as DME, MO due to BRVO, and CSC."
The Capabilities of Navigation in Microsecond Pulsing Laser Therapy. Prasad, P. Retinal Physician. June 2020. Read article
Summary: "Despite the growing number of therapeutic options available for the treatment of retinal vascular diseases, current therapies for these conditions are not always effective. Subthreshold laser, used either as monotherapy or in combination with other treatment options, may provide a safe way of targeting pathologic retinal lesions without damaging healthy tissue. Our preliminary experience thus far looks promising, especially when using this form of laser therapy as an adjuvant in pharmacotherapy-resistant patients. However, further studies with additional patients and longer follow-up are needed to determine optimal laser parameters and to demonstrate safety and efficacy in different retinal diseases. To that end, we are currently planning prospective studies to validate our initial positive experiences."
OD-OS Scores with Navilas® Microsecond Laser Platform. Results from subthreshold approaches in various posterior segment applications. by Hazlin Hassan. PIE Magazine. Sep/Oct 2019 read article
Summary:"Tracking the results from subthreshold studies To investigate these benefits, as well as safety and efficacy for treating retinal conditions using tissue-friendly microsecond pulsing approaches, several experts shared their experience with Navilas® during a satellite meeting at the recently held EURETINA congress in Paris, France."
Comparison of Photodynamic Therapy and Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy. Ntomoka, Cyprian Gabriel, Bindu Rajesh, Gachago Muchai Muriithi, Abhilash Goud, and Jay Chhablani. Eye, February 12, 2018. PubMed PMID: 29429986
Conclusion: "nMSL seems to be superior over PDT in improving visual and anatomical outcomes at 6 months and can be considered as a cheap alternative to PDT in treatment of CSCR."
Subthreshold microsecond laser for proliferative diabetic retinopathy: a randomized pilot study. Jhingan, Mahima; Goud, Abhilash; Peguda, Hari Kumar; Khodani, Mitali, Luttrull Jeffrey K; Chhablani, Jay. 2018. Clinical Ophthalmology 2018:12 141-145. PubMed PMID: 29391774
Conclusion: "This prospective pilot study proposes microsecond PRP is non-inferior to CWL PRP and could be an alternative to CWL PRP to avoid associated complications in cases of severe NPDR and early PDR."
Retinal Physician - Initial Experiences With Yellow Navigated Laser and Microsecond Pulses in Patients With DME. Kernt, Marcus “Retinal Physician. Accessed November 22, 2017. link
Summary: "Employing navigated laser in the treatment of retinal disease provides numerous advantages over conventional slit-lamp laser coagulation, including fast application of laser spots through prepositioning, precise, confluent and complete coverage of desired treatment areas, and integration of all imaging modalities to allow for the creation of a complete digital treatment plan. Our study, the first-ever comparison of three different navigated laser treatment parameters, indicates that all laser modalities could safely and easily be applied in a standard clinical setting."
Microsecond Yellow Laser for Subfoveal Leaks in Central Serous Chorioretinopathy. Ambiya, Vikas, Abhilash Goud, Annie Mathai, Padmaja Kumari Rani, and Jay Chhablani. Clinical Ophthalmology (Auckland, N.Z.) 10 (August 11, 2016): 1513. PubMed PMID: 27570446
Conclusion: "Microsecond laser is a safe and effective modality for treating cases of nonresolving CSC with subfoveal leaks."
Further publications with and about Navilas®
New Product Applications: Teleguided Planning Pays Off - Laser device allows surgeons to prepare for procedures ahead of time, offer tele-education. Retinal Physican. 2022. Link
"The Teleguidance feature for the Navilas Laser System 577s by OD-OS enables retina specialists to remotely log in and pre-plan retinal laser treatments, review treatment plans stored on the device, and observe live treatments performed by novice users. This remote access makes expert knowledge available when resources are limited. Simultaneously, the new software plugin device allows for tele-education opportunities, in which students can observe treatments remotely."
Application of 5G Technology to Conduct Real-Time Teleretinal Laser Photocoagulation for the Treatment of Diabetic Retinopathy. Chen, H., Pan, X., Yang, J., Fan, J., Qin, M., Sun, H., ... & Chen, Y. (2021). JAMA ophthalmology, 139(9), 975-982. Pubmed PMID: 34236391
Conclusion and relevance: "This study introduces a novel teleophthalmology paradigm to treat DR at a distance. Applying novel technologies may continue to ensure that remote patients with DR and other conditions have access to essential health care. Further studies will be needed to compare this approach with the current standard of care to determine whether visual acuity or safety outcomes differ."
Navigation technology/eye-tracking in ophthalmology: principles, applications and benefits—a narrative review. Kozak, I., Rahn, U. AES Annals of Eye Science. Vol 6 (March 2021)https://aes.amegroups.com/article/view/5776
Summary: "Ophthalmology is traditionally a technological leader among medical and surgical specialties. Early adoption of the principles of navigation technology is an example of why this is so. Navigation in ophthalmology spans from imaging diagnostics to most advanced laser and surgical procedures, such as the treatment of refractive errors, accurate placement of artificial IOLs, or most selective laser treatment of retinal diseases such as diabetic retinopathy. Navigation has made our decision making more detailed and our treatments more accurate and safer. The natural results of this are more standardized and predictable procedures with better treatment outcomes and increased patient satisfaction."
Topography-guided identification of leakage point in central serous chorioretinopathy: a base for fluorescein angiography-free focal laser photocoagulation. Maltsev, Dmitrii S; Kulikov, Alexei N; Chhablani, Jay.. Br J, Ophthalmol 2018; 0:1-8. PubMed PMID: 29301768
Conclusion: "This study demonstrates that PEDs localized in the upper half of the neurosensory detachment area and associated with the PROS thinning area coincided with the leakage point in a significant number of patients with CSC. The patients with non-resolving CSC with a small single PED localising in the upper one-third to one-half of the neurosensory detachment area with an area of PROS thinning above this PED may undergo FA-free OCT-guided FLP treating whole PED."
Evaluation of YAG-laser vitreolysis effectiveness based on quantitative characterization of vitreous floaters. Shaimova VA, Shaimov TB, Shaimov RB, Galin AY, Goloshchapova ZA, Ryzhkov PK, Fomin AV.. Vestn Oftalmol. 2018;134(1):56-62. PubMed PMID: 29543200
Conclusion: "Suggested methods of quantitative and qualitative assessment of artifactual shadows of the floaters in retinal layers are promising and may prove to be highly relevant for clinical monitoring of patients, optimization of treatment indications and evaluating effectiveness of YAG-laser vitreolysis. Further research of laser vitreolysis effectiveness in patients with vitreous floaters is necessary."
Teleophthalmology Image-Based Navigated Retinal Laser Therapy for Diabetic Macular Edema: A Concept of Retinal Telephotocoagulation. Kozak, Igor, John F. Payne, Patrik Schatz, Eman Al-Kahtani, and Moritz Winkler. “Graefe’s Archive for Clinical and Experimental Ophthalmology, April 26, 2017.
PubMed PMID: 28447201
Conclusion: "This study introduces the concept of retinal telephotocoagulation for diabetic macular edema, and demonstrates the feasibility and safety of using telemedicine to perform navigated retinal laser treatments regardless of geographical distance."
Shortening the Laser Photocoagulation Learning Curve with a Navigated System. Fassbender, Bernd. Retinal Physician. April 2017. link
Key Considerations: "Having the Navilas in my practice has improved practice efficiency. It is also preferred by patients and allows us to train doctors on photocoagulation safely and effectively."
Retro-Mode Scanning Laser Ophthalmoscopy Planning for Navigated Macular Laser Photocoagulation in Macular Edema. Boiko, Ernest V., and Dmitrii S. Maltsev. Journal of Ophthalmology 2016 (2016): 3726353. PubMed PMID: 26989498
Conclusion. "The RM-SLO image superimposed onto the fundus of the same eye can be used to guide MLP with narrow variability in treatment planning among retina specialists. The treatment areas suggested by RM-SLO-guided MLP plans for ME were shown to be larger than those suggested by OCT-guided plans."
Factors Affecting Laser Power in Retinal Navilas Laser Treatment. Hoeh, Alexandra E., Stefanie Pollithy, and Stefan Dithmar. Graefe’s Archive for Clinical and Experimental Ophthalmology 253, no. 6 (June 2015): 849–54. PubMed PMID: 25161075
Conclusions: "Among the examined parameters, focus setting had the strongest effect on the laser power needed to produce a mild visible burn. The association of focus with laser power can be explained by the focus-dependent change of retinal spot size. Lens status (phakic versus pseudophakic patients) seems to influence laser light transmission in the examined age group."
Navigated Laser (Navilas) Therapy For Choroidal Neovascular and Hyperpermeability Pathologies. Alshahrani, Saeed T., and Nicola G. Ghazi. Retinal Cases and Brief Reports 9, no. 2 (2015): 117–120. PubMed PMID: 25383841
Conclusion: "NAVILAS may be of utility in targeting choroidal vascular pathologies with laser."
Fluorescein Angiography versus Optical Coherence Tomography-Guided Planning for Macular Laser Photocoagulation in Diabetic Macular Edema. Kozak, Igor, Sharif Y. El-Emam, Lingyun Cheng, Dirk-Uwe Bartsch, Jay Chhablani, William R. Freeman, and J. Fernando Arevalo. “Retina (Philadelphia, Pa.) 34, no. 8 (2014): 1600. PubMed PMID: 24695064
Conclusion: "There is variability in the treatment planning for macular photocoagulation with a tendency to place more spots when guided by OCT than by FA. Integration of OCT map aligned to the retina may have an impact on treatment plan once such information is available."
Navigated Laser Therapy for Diabetic Macular Oedema. Kernt, Marcus, Michael Ulbig, Anselm Kampik, and Aljoscha S. Neubauer. European Ophthalmic Review 7, no. 2 (2013): 127–130. PubMed PMID: 23760425
Summary: "Both in the macular and the peripheral retina, the assistance systems of the Navilas laser provide high precision and safety in therapy, as well as additional advantages in terms of standardisation of planning and execution. In addition, digital documentation of laser spots and parameters allow for quality assurance in retinal laser therapy. Potential advantages of this technology over conventional laser become particularly obvious in focal macular laser therapy and consequently navigated laser therapy has been a primary focus as a treatment option for DMO without direct involvement of the fovea and – as a combination therapy with anti-VEGF injections – in DMO with foveal involvement."
Characterization of Microaneurysm Closure after Focal Laser Photocoagulation in Diabetic Macular Edema. Lee, Su Na, Jay Chhablani, Candy K. Chan, Haiyan Wang, Giulio Barteselli, Sharif El-Emam, Maria L. Gomez, Igor Kozak, Lingyun Cheng, and William R. Freeman. American Journal of Ophthalmology 155, no. 5 (May 2013): 905–912. PubMed PMID: 23394906
Conclusion: "Characterization of microaneurysms following focal laser photocoagulation resulted in hyperreflective spots and complete resolution of all reflectivity using SD-OCT. Smaller microaneurysms and those with heterogeneous lumen were positively associated with microaneurysm closure. These findings provide greater understanding of localized retinal changes following focal laser photocoagulation in DME treatment."
Focal Navigated Laser Photocoagulation in Retinovascular Disease: Clinical Results in Initial Case Series. Kozak, Igor, Jae Suk Kim, Stephen F. Oster, Jay Chhablani, and William R. Freeman. Retina (Philadelphia, Pa.) 32, no. 5 (May 2012): 930–35. PubMed PMID: 21886017
Conclusion: "Precise retinal targeting with a navigated laser photocoagulator resulted in highly accurate perifoveal laser application and no foveal damage. At 6 months after the treatment, significant decreases in central foveal thickness and significant improvements in visual acuity were identified."
Liesfeld, B., Amthor, K. U., Dowell, D., Weber, U., & Teiwes, W. (2009). Navigating comfortably across the retina. In World Congress on Medical Physics and Biomedical Engineering, September 7-12, 2009, Munich, Germany (pp. 243-246). Springer, Berlin, Heidelberg. link