Comparison of two-year treatment outcomes between subthreshold micropulse (577 nm) laser and aflibercept for diabetic macular edema

Lai, Frank Hiu Ping; Chan, Rose P. S.; Lai, Anthony Chuk-Him; Tsang, Susanna; Woo, Tiffany T. Y.; Lam, Robert F.; Yuen, Can Y. F.

doi:10.1007/s10384-021-00846-4

Cited by 8 publications

(5 citation statements)

References 29 publications

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“…A retrospective study by Lai et al 63 which included 164 eyes from 164 patients with centre-involving DMO and a CRT of > 300 µm treated with either SML (86 eyes) or intravitreal aflibercept monotherapy (78 eyes) found that although at the 6-month follow-up a higher percentage of eyes in the aflibercept group experienced at least a 5-letter visual acuity improvement when compared with those in the SML group (56% vs. 38%; p = 0.044), this was no longer the case at 12 months (45% vs. 49%; p = 0.584) or at 24 months (49% vs. 57%; p = 0.227). Similarly, although at the 6-month visit the aflibercept group had a higher percentage of eyes with an improvement of at least 10% in CRT than the SML group (73% vs. 49%; p = 0.005), this was no longer the case at the 12-month (73% vs. 70%; p = 0.995) or 24-month visits (85% vs. 84%; p = 0.872).…”

Section: Discussionmentioning

confidence: 99%

Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT

Lois

Campbell²,

Waugh

et al. 2022

Health Technol Assess

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Background The National Institute for Health and Care Excellence recommends macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm on optical coherence tomography. The DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser) trial compared standard threshold macular laser with subthreshold micropulse laser to treat diabetic macular oedema suitable for macular laser. Objectives Determining the clinical effectiveness, safety and cost-effectiveness of subthreshold micropulse laser compared with standard threshold macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm. Design A pragmatic, multicentre, allocation-concealed, double-masked, randomised, non-inferiority, clinical trial. Setting Hospital eye services in the UK. Participants Adults with diabetes and centre-involving diabetic macular oedema with a central retinal subfield thickness of < 400 µm, and a visual acuity of > 24 Early Treatment Diabetic Retinopathy Study letters (Snellen equivalent > 20/320) in one/both eyes. Interventions Participants were randomised 1 : 1 to receive 577 nm subthreshold micropulse laser or standard threshold macular laser (e.g. argon laser, frequency-doubled neodymium-doped yttrium aluminium garnet 532 nm laser); laser treatments could be repeated as needed. Rescue therapy with intravitreal anti-vascular endothelial growth factor therapies or steroids was allowed if a loss of ≥ 10 Early Treatment Diabetic Retinopathy Study letters between visits occurred and/or central retinal subfield thickness increased to > 400 µm. Main outcome measures The primary outcome was the mean change in best-corrected visual acuity in the study eye at 24 months (non-inferiority margin 5 Early Treatment Diabetic Retinopathy Study letters). Secondary outcomes included the mean change from baseline to 24 months in the following: binocular best-corrected visual acuity; central retinal subfield thickness; the mean deviation of the Humphrey 10–2 visual field in the study eye; the percentage of people meeting driving standards; and the EuroQol-5 Dimensions, five-level version, National Eye Institute Visual Function Questionnaire – 25 and Vision and Quality of Life Index scores. Other secondary outcomes were the cost per quality-adjusted life-years gained, adverse effects, number of laser treatments and additional rescue treatments. Results The DIAMONDS trial recruited fully (n = 266); 87% of participants in the subthreshold micropulse laser group and 86% of participants in the standard threshold macular laser group had primary outcome data. Groups were balanced regarding baseline characteristics. Mean best-corrected visual acuity change in the study eye from baseline to month 24 was –2.43 letters (standard deviation 8.20 letters) in the subthreshold micropulse laser group and –0.45 letters (standard deviation 6.72 letters) in the standard threshold macular laser group. Subthreshold micropulse laser was deemed to be not only non-inferior but also equivalent to standard threshold macular laser as the 95% confidence interval (–3.9 to –0.04 letters) lay wholly within both the upper and lower margins of the permitted maximum difference (5 Early Treatment Diabetic Retinopathy Study letters). There was no statistically significant difference between groups in any of the secondary outcomes investigated with the exception of the number of laser treatments performed, which was slightly higher in the subthreshold micropulse laser group (mean difference 0.48, 95% confidence interval 0.18 to 0.79; p = 0.002). Base-case analysis indicated no significant difference in the cost per quality-adjusted life-years between groups. Future work A trial in people with ≥ 400 µm diabetic macular oedema comparing anti-vascular endothelial growth factor therapy alone with anti-vascular endothelial growth factor therapy and macular laser applied at the time when central retinal subfield thickness has decreased to < 400 µm following anti-vascular endothelial growth factor injections would be of value because it could reduce the number of injections and, subsequently, costs and risks and inconvenience to patients. Limitations The majority of participants enrolled had poorly controlled diabetes. Conclusions Subthreshold micropulse laser was equivalent to standard threshold macular laser but required a slightly higher number of laser treatments. Trial registration This trial is registered as EudraCT 2015-001940-12, ISRCTN17742985 and NCT03690050. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 50. See the NIHR Journals Library website for further project information.

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Section: Discussionmentioning

confidence: 99%

Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT

Lois

Campbell²,

Waugh

et al. 2022

Health Technol Assess

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“…Their combined use was demonstrated, in fact, to significantly reduce the number of anti-VEGF injections while preserving or even improving morpho-functional outcomes. BCVA improvement and a CMT decrease were illustrated in two thirds [ 55 , 56 , 58 – 61 , 63 ] and in half of the studies considered [ 55 , 58 – 61 ], respectively, and a stabilization of these features was described in the remaining cases throughout the entire follow-up [ 56 , 57 , 62 – 64 ].…”

Section: Clinical Applicationsmentioning

confidence: 99%

“…Of note, only two studies reported no significant differences within the cohorts treated with anti-VEGF therapy and anti-VEGF + YSML in terms of number of injections needed [ 62 , 64 ].…”

Section: Clinical Applicationsmentioning

confidence: 99%

Yellow Subthreshold Micropulse Laser in Retinal Diseases: An In-Depth Analysis and Review of the Literature

et al. 2023

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Yellow subthreshold micropulse laser (YSML) is a retinal laser capable of inducing a biologic response without causing thermal damage to the targeted tissue. The 577-nm YSML is delivered to the retina abiding by different protocols in which wavelength, power, duration, spot size and number of spots can be properly set to achieve the most effective and safe treatment response in various chorioretinal disorders. The ultrashort trains of power modulate the activation of the retinal pigment epithelium cells and intraretinal cells, such as Müller cells, causing no visible retinal scars. Subthreshold energy delivered by YSML stimulates the production of the heat-shock proteins, highly conserved molecules that protect cells against any sort of stress by blocking apoptotic and inflammatory pathways that cause cell damage. YSML treatment allows resorption of the subretinal fluid in central serous chorioretinopathy and intraretinal fluid in various conditions including diabetic macular edema, postoperative cystoid macular edema and other miscellaneous conditions. YSML also seems to modulate the development and progression of reticular pseudodrusen in dry age-related macular degeneration. The aim of this review is to discuss and summarize the safety and efficacy of YSML treatment in retinal diseases.

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“…A recent retrospective study by Lai et al [88] presented that aflibercept monotherapy resulted in short-term higher functional and anatomical improvement compared to that resulting from the MPLT with rescue aflibercept therapy, however, the long-term results did not show any significant differences. In contrast to other studies, MPLT was not preceded by initial anti-VEGF injections, and it was performed with focal conventional laser treatment of microaneurysms.…”

Section: Subthreshold Micropulse Laser Treatment and Intravitreal The...mentioning

confidence: 96%

Subthreshold Micropulse Laser for Diabetic Macular Edema: A Review

Sabal

Teper

Wylęgała

2022

JCM

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Diabetic macular edema (DME) is one of the main causes of visual impairment in patients of working age. DME occurs in 4% of patients at all stages of diabetic retinopathy. Using a subthreshold micropulse laser is an alternative or adjuvant treatment of DME. Micropulse technology demonstrates a high safety profile by selectively targeting the retinal pigment epithelium. There are no standardized protocols for micropulse treatment, however, a 577 nm laser application over the entire macula using a 200 μm retinal spot, 200 ms pulse duration, 400 mW power, and 5% duty cycle is a cost-effective, noninvasive, and safe therapy in mild and moderate macular edemas with retinal thickness below 400 μm. Micropulse lasers, as an addition to the current gold-standard treatment for DME, i.e., anti-vascular endothelial growth factor (anti-VEGF), stabilize the anatomic and functional retinal parameters 3 months after the procedure and reduce the number of required injections per year. This paper discusses the published literature on the safety and application of subthreshold micropulse lasers in DME and compares them with intravitreal anti-VEGF or steroid therapies and conventional grid laser photocoagulation. Only English peer-reviewed articles reporting research within the years 2010–2022 were included.

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Comparison of two-year treatment outcomes between subthreshold micropulse (577 nm) laser and aflibercept for diabetic macular edema

Cited by 8 publications

References 29 publications

Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT

Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT

Yellow Subthreshold Micropulse Laser in Retinal Diseases: An In-Depth Analysis and Review of the Literature

Subthreshold Micropulse Laser for Diabetic Macular Edema: A Review

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