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Can subthreshold micropulse yellow laser treatment change the anti-vascular endothelial growth factor algorithm in diabetic macular edema? A randomized clinical trial.

ABSTRACT: Purpose:To compare the efficacy of subthreshold micropulse yellow laser (SMYL) and intravitreal aflibercept injection (IAI) combination therapy with IAI monotherapy in the treatment of diabetic macular edema (DME) and to evaluate the number of injections and SMYL sessions required. Methods:This prospective study compared a group of 28 patients treated with a combination of SMYL and IAI with a group of 28 patients treated only with IAI. All patients initially received 3 monthly IAIs, and the monotherapy group was given additional injections as needed. The combination therapy patients additionally received SMYL after the loading phase. The primary outcome measures were the change in the best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to month 12; the secondary outcomes were the mean number of required injections and SMYL sessions. Results:In the monotherapy group, the BCVA improved from 0.38 ± 0.10 to 0.20 ± 0.10 logMAR; in the combination group, BCVA improved from 0.40 ± 0.09 to 0.17 ± 0.06 logMAR at the end of the 12th month. The CMT was reduced from 451.28 ± 44.85 to 328.8 ± 49.69 ?m in the monotherapy group and from 466.07 ± 71.79 to 312.0 ± 39.29 ?m in the combination group. Improvement of the mean BCVA and reduction of the mean CMT were similar in each group. The combination group required significantly fewer injections (3.21 ± 0.41 vs 5.39 ± 1.54; P < 0.001). By month 12, 75% of patients in the monotherapy group had required additional IAIs when compared with 16% in the combination group (P < 0.001). Conclusion:SMYL combination therapy demonstrated significant visual improvements in patients with DME. In the combination group, the retreatment rate and number of required injections were significantly lower compared with the IAI monotherapy group.

SUBMITTER: Kanar HS

PROVIDER: S-EPMC6951119 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Can subthreshold micropulse yellow laser treatment change the anti-vascular endothelial growth factor algorithm in diabetic macular edema? A randomized clinical trial.

Kanar Hatice Selen HS Arsan Aysu A Altun Ahmet A Akı Suat Fazıl SF Hacısalihoglu Aynur A

Indian journal of ophthalmology 20200101 1

<h4>Purpose</h4>To compare the efficacy of subthreshold micropulse yellow laser (SMYL) and intravitreal aflibercept injection (IAI) combination therapy with IAI monotherapy in the treatment of diabetic macular edema (DME) and to evaluate the number of injections and SMYL sessions required.<h4>Methods</h4>This prospective study compared a group of 28 patients treated with a combination of SMYL and IAI with a group of 28 patients treated only with IAI. All patients initially received 3 monthly IAI ...[more]

PMID: 31856493

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Project description:The purpose of the study was to assess both anatomic and functional outcomes between short-pulse continuous wavelength and infrared micropulse lasers in the treatment of DME. This was a prospective interventional study from tertiary care eye hospital-King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). Patients with center-involving diabetic macular edema were treated with subthreshold laser therapy. Patients in the micropulse group were treated with the 810-nm diode micropulse scanning laser TxCell (IRIDEX Corporation, Mountain View, CA, USA) (subthreshold micropulse-STMP group). Laser was applied according to recommendations for MicroPulse (125 microns spot size, 300 ms pulse duration and power adjustment following barely visible testing burn) in a confluent mode (low intensity/high density) to the entire area of the macular edema. Patients in the short-pulse group were treated with grid pattern laser with 20 ms pulse PASCAL laser 532 nm (TopCon Medical Laser Systems, Tokyo, Japan) with EndPoint algorithm, which was either 30% or 50% of testing burn (EndPoint 30% and EndPoint 50% groups, respectively). Main outcome measures included best-corrected visual acuity (BCVA in logMAR) and foveal thickness at baseline and the last follow-up visit at 6 months. There were 44 eyes in the micropulse group, 54 eyes in the EndPoint 50% group and 18 eyes in the EndPoint 30% group. BCVA for the whole cohort (logMAR) was 0.451 (Snellen equivalent 20/56) at baseline, 0.495 (Snellen equivalent 20/62) (p = 0.053) at 3 months, and 0.494 (Snellen equivalent 20/62) at the last follow-up (p = 0.052). Foveal thickness for the whole cohort was 378.2 ± 51.7 microns at baseline, 347.2 ± 61.3 microns (p = 0.002) at 3 months, and 346.0 ± 24.6 microns at the final follow-up (p = 0.027). As such the short-pulse system yields more temporary reduction in edema. Comparison of BCVA between baseline and 6 months for EndPoint 30%, EndPoint 50% and STMP groups was p = 0.88, p = 0.76 and p = 0.003, respectively. Comparison of foveal thickness between baseline and 6 months for EndPoint 30%, EndPoint 50% and STMP groups was p = 0.38, p = 0.22 and p = 0.14, respectively. We conclude that the infrared micropulse system seems to improve functional outcomes. When applied according to previously published reports, short-pulse system may yield more temporary reduction in edema while infrared micropulse system may yield slightly better functional outcomes.

Project description:BackgroundIn the UK, macular laser is the treatment of choice for people with diabetic macular oedema with central retinal subfield thickness (CST) <?400??m, as per National Institute for Health and Care Excellence guidelines. It remains unclear whether subthreshold micropulse laser is superior and should replace standard threshold laser for the treatment of eligible patients.MethodsDIAMONDS is a pragmatic, multicentre, allocation-concealed, randomised, equivalence, double-masked clinical trial that aims to determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser compared with standard threshold laser, for the treatment of diabetic macular oedema with CST <?400??m. The primary outcome is the mean change in best-corrected visual acuity in the study eye from baseline to month 24 post treatment. Secondary outcomes (at 24?months) include change in binocular best corrected visual acuity; CST; mean deviation of the Humphrey 10-2 visual field; change in percentage of people meeting driving standards; European Quality of Life-5 Dimensions, National Eye Institute Visual Functioning Questionnaire-25 and VisQoL scores; incremental cost per quality-adjusted life year gained; side effects; number of laser treatments and use of additional therapies. The primary statistical analysis will be per protocol rather than intention-to-treat analysis because the latter increases type I error in non-inferiority or equivalence trials. The difference between lasers for change in best-corrected visual acuity (using 95% CI) will be compared to the permitted maximum difference of five Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Linear and logistic regression models will be used to compare outcomes between treatment groups. A Markov-model-based cost-utility analysis will extend beyond the trial period to estimate longer-term cost-effectiveness.DiscussionThis trial will determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser, when compared with standard threshold laser, for the treatment of diabetic macular oedema, the main cause of sight loss in people with diabetes mellitus.Trial registrationInternational Standard Randomised Controlled Trials, ISRCTN17742985 . Registered on 19 May 2017 (retrospectively registered).

Project description:BackgroundDiabetic macular edema (DME) is the main cause of visual loss in diabetic patients. Despite the use of anti-VEGF therapy as first-line treatment, there are many patients whose response to treatment is poor or transient at best. Sophisticated laser techniques have emerged aiming at low-intensity retinal damage, avoiding excessive heat that causes tissue necrosis and related collateral effects.ObjectiveTo evaluate the effect of combined sublethal laser modalities from short-pulse duration (SPD) with endpoint management (EpM) subthreshold laser [named the "sandwich technique" (SWiT)] on central subfield thickness (CST) and best-corrected visual acuity (BCVA) in patients with DME.Material and methodsIn this consecutive retrospective study, 37 patients (37 eyes) with center-involved (CI) DME were treated with SWiT laser therapy from April 2017 to June 2021. The technique consisted of a mean number of 200 (range number 50-400) SPD laser burns OCT-guided thickened area performed on the juxta- and perifoveal area 500 µm away from the foveal center, overlapping with a mean number of 1000 (range number 800-1200) EpM laser burns focused on 6 mm macular diameter area but saving 300 µm toward the foveal center. All patients underwent ophthalmological evaluations, including BCVA and CST measurement by spectral-domain optical coherence tomography (SD-OCT), before and after SWiT laser therapy. The mean follow-up time was 19.2 months (range 2-60 months).ResultsThirty-five out of 37 cases showed an improvement in CST and BCVA following treatment. At baseline, mean CST (µm) ± standard error (SE) and mean BCVA (logMAR) ± SE was 456.95 ± 37.00 and 0.71 ± 0.29, respectively. After a mean follow-up of 19.2 months, mean CST (µm) ± SE and BCVA (logMAR) ± SE were 272.09 ± 9.10 (p < 0.0001) and 0.54 ± 0.26 (p = 0.003), respectively. A statistically significant reduction in CST and improvement in BCVA was noted after laser therapy application. The anti-VEGF injection frequency was reduced during the mean 19.2 months of the study period.ConclusionsThe novel "sandwich" laser therapy aid reduced CST and improved BCVA in this retrospective case series. Further prospective studies are warranted.

Project description:ObjectivesTo estimate the economic costs, health-related quality-of-life outcomes and cost-effectiveness of subthreshold micropulse laser (SML) versus standard laser (SL) for the treatment of diabetic macular oedema (DMO) with central retinal thickness (CRT) of <400µ.DesignAn economic evaluation was conducted within a pragmatic, multicentre, randomised clinical trial, DIAbetic Macular Oedema aNd Diode Subthreshold.Setting18 UK Hospital Eye Services.ParticipantsAdults with diabetes and centre involving DMO with CRT<400µ.InterventionsParticipants (n=266) were randomised 1:1 to receive SML or SL.MethodsThe base-case used an intention-to-treat approach conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective. Costs (2019-2020 prices) were collected prospectively over the 2-year follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit of SML in comparison to SL. Sensitivity analyses explored uncertainty and heterogeneity in cost-effectiveness estimates.ResultsOne participant in the SL arm withdrew consent for data to be used; data from the remaining 265 participants were included in analyses. Mean (SE) NHS and PSS costs over 24 months were £735.09 (£111.85) in the SML arm vs £1099.70 (£195.40) in the SL arm (p=0.107). Mean (SE) QALY estimates were 1.493 (0.024) vs 1.485 (0.020), respectively (p=0.780), giving an insignificant difference of 0.008 QALYs. The probability SML is cost-effective at a threshold of £20 000 per QALY was 76%.ConclusionsThere were no statistically significant differences in EQ-5D-5L scores or costs between SML and SL. Given these findings and the fact that SML does not burn the retina, unlike SL and has equivalent efficacy to SL, it may be preferred for the treatment of people with DMO with CRT<400µ.Trial registration numbersISRCTN17742985; NCT03690050.

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Can subthreshold micropulse yellow laser treatment change the anti-vascular endothelial growth factor algorithm in diabetic macular edema? A randomized clinical trial.

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Can subthreshold micropulse yellow laser treatment change the anti-vascular endothelial growth factor algorithm in diabetic macular edema? A randomized clinical trial.

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