Laser For Diabetic Macular Edema Research Articles

Comparing functional and vascular layer outcomes of laser photocoagulation versus subthreshold micropulse laser for diabetic m.

To compare the efficacy of conventional laser (CL) and subthreshold micropulse laser (SML) for treating diabetic macular edema in terms of functional outcomes and changes in quantitative metrics for the retinal capillary and choriocapillary vascular layers. Fifty-two eyes from 52 patients with treatment-naïve clinically significant macular edema were randomly assigned to the CL or SML group in a 1:1 ratio. Best-corrected visual acuity, central macular thickness (CMT) and optical coherence tomography angiography (OCT-A) scans were measured at baseline, 1-, 3- and 6-months post-treatment. The SML group showed rapid visual recovery, improving from baseline of 0.320 ± 0.31 logMAR (20/42 Snellen) to 0.270 ± 0.22 logMAR (20/37 Snellen) at 1 month (p = 0.038); and had significant improvements in CMT at 6-month post-treatment (353.88 to 301.00µm, p = 0.005). Statistically significant changes were detected across all OCT-A metrics, including vessel density (VD), vessel length density (VLD), vessel diameter index (VDI) and fractal dimension (FD), at 6 months for both groups in the deep capillary plexus (DCP) and choriocapillary plexus (CCP). SML resulted in early visual recovery and sustained macular thickness improvement in the treatment of DME. Microvascular perfusion parameters, including VD, VLD and FD, improved in the DCP and CCP for both treatment groups at 6-months post-treatment.

Subthreshold Micropulse Laser for Diabetic Macular Edema: A Review.

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.

Anti-VEGF Monotherapy versus Combined Anti-VEGF and Endpoint Management Laser for Diabetic Macular Edema (END-DME Study)

Miho Nozaki, Ian Y Wong, Ryo Kawasaki, Joo Eun Lee, Yoshihiro Takamura, Ji Eun Lee, Shigeo Yoshida, Jae Pil Shin, Teruyo Kida, Woohyok Chang, Eiko Tsuiki, Hidetaka Noma, Kiyoshi Suzuma. J Retin 2022;7:65-74. https://doi.org/10.21561/jor.2022.7.2.65

The efficacy of micropulse laser combined with ranibizumab in diabetic macular edema treatment: study protocol for a randomized controlled trial

BackgroundAt present, intraocular injection of anti-VEGF (vascular endothelial growth factor) drugs has replaced traditional laser therapy as the first-line treatment for DME (diabetic macular edema). However, ranibizumab, a commonly used anti-VEGF drug, is expensive and requires multiple intraocular injections. It places a heavy economic burden on patients with DME. Micropulse laser is safer than conventional laser and can reduce edema. Combined treatment with anti-VEGF may reduce the number of intraocular injections. This study will compare the efficacy of micropulse laser combined with ranibizumab treatment to ranibizumab monotherapy in the treatment of DME, providing a new regimen for future DME treatment.MethodsThis study is a prospective randomized double-blind controlled clinical trial (RCT) in patients with DME. After 1-year follow-up, visual acuity and macular edema regression will be compared between micropulse laser combined with ranibizumab group and ranibizumab monotherapy group to determine whether the efficacy of micropulse laser combined with ranibizumab treatment was not lower than that of ranibizumab monotherapy in the treatment of DME. Visual acuity measured by the ETDRS chart is the primary outcome measure. The secondary outcome measures are CMT (central macular thickness) measured by OCT (optical coherence tomography) and the number of injections of two groups. Changes in visual acuity and CMT of the two groups will be compared at 12-month follow-up. Before patients are recruited, we provide them with informed consent, in which we explain to them the purpose and process of the study.DiscussionMicropulse laser combined with anti-VEGF drugs in the treatment of DME can reduce the number of intravitreal anti-VEGF injections, not only relieve the pain of the patients, but also ease the economic and psychological burden of patients, bringing great benefits. However, there is no treatment consensus for the parameters and specific methods of micropulse laser treatment for DME. There is a lack of clinical research data reference of micropulse laser combined with anti-VEGF therapy in clinical practice. This study intends to provide a new direction for clinical DME treatment and also provide a realistic consideration for the application of micropulse laser in DME treatment.Trial registrationClinicalTrials.gov NCT03690947. Registered on 1 October 2018.

Laser in diabetic macular edema

Laser photocoagulation has been an integral part of the management of diabetic macular edema (DME) for decades. And despite the dramatic changes in retinal imaging and the availability of new treatment options over the years it is still has a role in the pharmacotherapy era. First, as a supplementary treatment in eyes with CI-DME inadequately responding to antiVEGFs and steroids; to reduce the number and frequency of injections. And secondly, it is the only scientifically proven option for eyes with non CIDME with CSME features.

Comparison of short-pulse subthreshold (532\xa0nm) and infrared micropulse (810\xa0nm) macular laser for diabetic macular edema

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.

Results of Intravitreal Bevacizumab as an Adjunct to mETDRS Grid Laser in Diabetic Macular Edema

Purpose: To assess the efficacy of Intravitreal Bevacizumab as an adjuvant to grid laser photocoagulation in patients with diffuse macular edema (DME) in type II diabetes.
 Study Design: Quasi experimental study.
 Place and Duration of Study: Institute of ophthalmology, Liaquat University of Medical and Health Sciences, Jamshoro, from September 2016 to November 2018
 Methods: Ninety five patients with diffuse macular edema in type II diabetes were selected by convenient sampling. Group I patients were treated with ETDRS grid laser photocoagulation. Group II patients were treated with ETDRS grid laser photocoagulation followed by intravitreal bevacizumab after one week monthly for 2 months and then as per need. All patients were examined after 1st, 2nd and 3rd month and mean change in best corrected visual acuity (BCVA) and central macular thickness (CMT).Statistical analysis was done on SPSS version 20.0. Paired t-test was used to compare mean values and p valve < 0.05 was accepted as statistically significant.
 Results: The results of study were compared with the baseline values. The mean change in BCVA in group 1 was from 46 ± 18 letters to 52 ± 17. BCVA in group 2 was from 46 ± 18 letters to 56 ± 17 (P < 0.001). The decrease in macular edema thickness was more in group II than group I (P < 0.001).
 Conclusion: Macular Grid laser with or without Intravitreal Bevacizumab significantly improves vision and decreases macular edema but combined treatment led to more stable improvement in DME during follow-up.
 Key Words: Modified ETDRS laser, Bevacizumab, Macular edema, Anti-VEGF.

Subthreshold Micropulse Laser in Diabetic Macular Edema: 1-Year Improvement in OCT/OCT-Angiography Biomarkers

PurposeThe aim of this study was to evaluate 1-year quantitative changes in specific inflammatory parameters on optical coherence tomography (OCT) / optical coherence tomography angiography (OCTA) in diabetic macular edema (DME) treated with subthreshold micropulse laser (SMPL).MethodsThirty-seven patients / eyes with previously treatment-naïve DME treated with SMPL were prospectively evaluated at 3, 6, and 12 months. Fifteen fellow eyes with only microaneurysms (MAS) not eligible for treatment were controls. Evaluated OCT / OCTA parameters included: central macular thickness (CMT); hyper-reflective retinal spots (HRS); disorganization of inner retinal layers (DRILs); MA in the superficial / deep capillary plexuses (SCP/DCP); cysts in the area at the SCP / DCP; and macular perfusion parameters (MATLAB, version 2017b).ResultsIn the treated group, mean best corrected visual acuity (BCVA) progressively increased from 69.4 ± 12.0 to 76.0 ± 9.1 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (P < 0.001) at 12 months; HRS decreased from baseline (80.75 ± 20.41) at 3 (73.81 ± 17.1, P = 0.002), 6 (69.16 ± 16.48, P < 0.0001), and 12 months (66.29 ± 18.53, P < 0.0001). MA decreased at 3 months in the DCP (P = 0.015), at 6 and 12 months in both plexuses (P ≤ 0.0007). BCVA, HRS, and MA remained stable in the controls during all follow-ups. DRIL was present in 18 of 37 patients at baseline and progressively decreased from 557.0 ± 238.7 to 387.1 ± 282.1 μm (P = 0.01). The area of cyst decreased both in the SCP (P = 0.03) and the DCP (P = 0.02). CMT and perfusion parameters did not change.ConclusionsSMPL reduced the number of HRS (sign of activated microglia cells in the retina), MA, DRIL extension, and the area of cysts. Further studies are needed to confirm these preliminary data on the anti-inflammatory effect of SMPL, and to explore the mechanism of action.Translational RelevanceThe follow-up of OCT/OCTA noninvasive biomarkers offers a unique insight in the mechanism of laser action, suggesting an anti-inflammatory effect of SMPL.

CHANGES OF AQUEOUS HUMOR MÜLLER CELLS' BIOMARKERS IN HUMAN PATIENTS AFFECTED BY DIABETIC MACULAR EDEMA AFTER SUBTHRESHOLD MICROPULSE LASER TREATMENT.

To evaluate the changes in activity of biomarkers of Mu[Combining Diaeresis]ller cells (MC) in aqueous humor of patients with diabetic macular edema after subthreshold micropulse laser, over 1 year. Patients with untreated diabetic macular edema and central retinal thickness ≤ 400 μm were enrolled. Best-corrected visual acuity, full ophthalmic examination, and optical coherence tomography were performed. Subthreshold micropulse laser was applied every 3 months. Glial fibrillary acidic protein and inwardly rectifying potassium channel (Kir 4.1), MC activity markers, and vascular endothelial growth factor were quantified in the aqueous humor collected at baseline and at 1, 3, and 12 months after laser. Changes in the macular thickness and inner nuclear layer thickness, where MC bodies are located, were measured. Ten eyes of 10 patients were included. Best-corrected visual acuity improved at 3 months (P = 0.047) and remained stable. Inner nuclear layer thickness significantly reduced at 12 months (P = 0.012). Glial fibrillary acidic protein, Kir 4.1, and vascular endothelial growth factor decreased at 1 and/or 3 and/or 12 months compared with baseline (P < 0.05). Subthreshold micropulse laser improves visual function in diabetic macular edema. Kir 4.1 and glial fibrillary acidic protein decrease and inner nuclear layer thickness reduction demonstrate that subthreshold micropulse laser may restore MC function. Subthreshold micropulse laser also reduces vascular endothelial growth factor concentration. The effect of subthreshold micropulse laser in diabetic macular edema may in part be due to changes of MC metabolic activity.

Commentary: Subthreshold micropulse yellow laser in diabetic macular edema.

Commentary: Subthreshold micropulse yellow laser in diabetic macular edema.

Visual outcomes following intravitreal bevacizumab and focal laser in diabetic macular edema

Purpose: The aim of this study was to evaluate the visual outcome and central macular thickness (CMT) after intravitreal injection of bevacizumab followed by focal laser for the treatment of Diabetic Macular Edema (DME). Patients and methods: This is a prospective, observational study. A total of 30 eyes of 30 patients with Diabetic macular edema were included in this study. The following data were recorded at baseline and during the follow-up periods (≤6 months): best-corrected visual acuity (BCVA), slit-lamp biomicroscopy, CMT and intraocular pressure measurement by applanation tonometry. All eyes received intravitreal bevacizumab at a dose of 1.25 mg in 0.05 ml followed by focal laser after 2 weeks. Results: This study included 30 eyes of 30 patients, the mean age of the patient 59.4±8.5 years. There were 19 males and 11 females. The mean baseline BCVA in LogMAR was 0.78±0.23, and the final mean BCVA at 6 months had improved to 0.45±0.20. Significant improvement was seen in all the patients over the study period (p&lt;0.001). Mean CMT at baseline was 485±122 μm, which decreased to a mean of 321±82μm at the end of the follow-up period (6 months). Conclusion: Primary treatment for DME with intravitreal bevacizumab followed by focal laser results in improvement of vision and reduces CMT. Combined therapy seems to be an effective modality for treatment of DME.

Intravitreal Ranibizumab Monotherapy or Combined with Laser for Diabetic Macular Edema (OCT guided study)

Background: Diabetic retinopathy (DR) is the most frequent ocular complication of diabetes mellitus and the leading cause of blindness in the working age population in developing countries. Objective: The aim of this study was to compare central macular thickness using optical coherence tomography (OCT) between Ranibizumab 0.5 mg monotherapy over Ranibizumab 0.5 mg combined with laser based on mean average change in best-corrected visual acuity (BCVA) over 6 months in diabetic macular edema (DME). Patients and methods: The study was carried out on forty eyes of patients aged 30-75 years old, with type 1 or 2 diabetes mellitus and have visual impairment due to DME. The patients were selected from the Outpatient Ophthalmology Clinic of Aswan University Hospital. Results: Both groups achieved improvement of visual acuity and reduction of the macular thickness but the effect was more pronounced and long lasting in the combined therapy group. Conclusion: The use of more than one line of treatment in combination for patients with diffuse DME could provide more sustained results with the need for less frequent injections and decreasing the recurrence or persistence rate of DME.

Intravitreal Ranibizumab Monotherapy or Combined with Laser for Diabetic Macular Edema (OCT guided study)

Background: Diabetic retinopathy (DR) is the most frequent ocular complication of diabetes mellitus and the leading cause of blindness in the working age population in developing countries. Objective: The aim of this study was to compare central macular thickness using optical coherence tomography (OCT) between Ranibizumab 0.5 mg monotherapy over Ranibizumab 0.5 mg combined with laser based on mean average change in best-corrected visual acuity (BCVA) over 6 months in diabetic macular edema (DME). Patients and methods: The study was carried out on forty eyes of patients aged 30-75 years old, with type 1 or 2 diabetes mellitus and have visual impairment due to DME. The patients were selected from the Outpatient Ophthalmology Clinic of Aswan University Hospital. Results: Both groups achieved improvement of visual acuity and reduction of the macular thickness but the effect was more pronounced and long lasting in the combined therapy group. Conclusion: The use of more than one line of treatment in combination for patients with diffuse DME could provide more sustained results with the need for less frequent injections and decreasing the recurrence or persistence rate of DME.

Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema

Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema

Navigated laser in diabetic macular edema: the impact of reduced injection burden on patients and physicians-who wins and who loses?

We inquired the impact of reduced therapy discontinuation in diabetic macular edema (DME) on physician's revenue considering anti-vascular endothelial growth factor (VEGF) monotherapy and its combination with Navilas treatment. Data were collected on injection frequency, treatment discontinuation and reimbursement fees for DME treatment with anti-VEGF compared to anti-VEGF in combination with navigated laser. Based on these data an economic model was built to compare physicians revenue over a 5y period using either therapy for 4 European countries and the USA. 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.

Single Retinal Layer Changes After Subthreshold Micropulse Yellow Laser in Diabetic Macular Edema.

A pilot prospective, interventional study has been conducted on 10 patients with diabetic macular edema (DME) treated with subthreshold micropulse laser (SMPL) to evaluate changes of individual retinal layers and to correlate with functional changes. All patients underwent complete ophthalmologic evaluation including spectral-domain optical coherence tomography (OCT) and microperimetry at baseline, 3 months, 6 months, 9 months, and 12 months. Compared with baseline, a significant decrease was found in inner nuclear layer (INL) and outer retinal layer (ORL) thickness in the central 1 mm (P < .05). Increase in best-corrected visual acuity was significantly and inversely correlated to central retinal thickness (CRT) (P = .0027), INL (P = .0167), and outer nuclear layer (ONL) thickness (P = .0107). Increase in retinal sensitivity was significantly and inversely correlated to CRT and ONL thickness (P < .01). Therefore, SMPL showed to improve firstly functional parameters and then morphologic parameters. Functional parameters were inversely correlated to CRT, INL, and ONL thickness. The exact mechanism of reduction of INL thickness induced by SMPL remains to be further evaluated. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:e218-e225.].

Intravitreal injection of Ranibizumab combined with laser for diabetic macular edema

Intravitreal injection of Ranibizumab combined with laser for diabetic macular edema

In Vivo Study of the Long Term Structural Changes Induced by Macular Argon Laser

ABSTRACTPurpose: To assess the long-term structural changes induced by macular argon laser using en face optical coherence tomography (OCT).Materials and Methods: We reviewed the charts and OCT pictures of patients who had undergone macular laser for diabetic macular edema at least four years ago. Clinical parameters were recorded for each eye, including laser settings. We obtained En face pictures, that were flattened at the RPE (retinal pigment epithelium) plane. We then measured the retinal surface covered by laser marks and the maximal diameter of the largest identified lesion at this plane. The most superficial level of neurosensory retinal damage as well as the total retinal thickness at this location were measured from the RPE. We also measured the distance between the RPE and the deeper plane at which laser marks were detected.Results: 21 eyes of 16–patients were analyzed. The mean age (±SD) was 61.7 ± 15.5 years. Patients had undergone macular laser 6.5 ± 2.8 years prior to entering our study. In 16 eyes the most superficial laser marks were detected at the inner plexiform/inner nuclear layers. The level of neurosensory retinal damage was 159 ± 48 microns over the RPE (62.6 ± 18.3% of the retinal thickness). The deepest level at which laser marks were retrieved was 125 ± 110 microns below the RPE. The growth of laser marks was correlated to time (Pearson’s correlation coefficient = 0.23; p = 0.1).Conclusions: Argon laser marks gradually expand in the horizontal and vertical axes. The damage induced by argon laser in the neurosensory retina often reaches inner layers.

Baseline Factors Affecting Changes in Diabetic Retinopathy Severity Scale Score After Intravitreal Aflibercept or Laser for Diabetic Macular Edema: Post Hoc Analyses from VISTA and VIVID

To evaluate whether select baseline systemic and ocular factors influence ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score at week 100 in VISTA and VIVID. Post hoc analysis of 2 similarly designed phase 3 trials, VISTA and VIVID. Total of 456 patients with center-involved diabetic macular edema (DME). VISTA and VIVID randomized 872 DME patients to receive intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or macular laser photocoagulation. This post hoc analysis evaluated the influence of select baseline factors on ≥2-step DRSS score improvement by logistic regression in an integrated VISTA and VIVID dataset using observed cases (n= 456) with patients in each treatment group divided into tertiles based on each characteristic. Proportion of patients with ≥2-step improvement in DRSS score from baseline at week 100 by age, duration of diabetes, hemoglobin A1c (HbA1c), body mass index (BMI), best-corrected visual acuity (BCVA), central subfield thickness (CST), and DRSS score. At week 100, 10.1%, 34.3%, and 37.6% of patients in the laser, 2q4, and 2q8 groups experienced a ≥2-step DRSS score improvement, respectively. Age, duration of diabetes, HbA1c, BMI, BCVA, and CST had no impact on the ability to achieve ≥2-step improvement in DRSS score. Initial DRSS score was the only factor significantly associated with ≥2-step DRSS score improvement in all treatment groups at weeks 24, 52, 76, and 100. Relatively higher proportions of IAI-treated patients with worse BCVA or thicker CST experienced ≥2-step DRSS score improvement compared with those with better BCVA or thinner CST, respectively, but these associations were not statistically significant. A strong association was present between baseline DRSS score and ≥2-step DRSS score improvement at week 100 for DME patients in VISTA and VIVID.

The Role of Focal Laser in the Anti-Vascular Endothelial Growth Factor Era.

Introduction:To review important studies examining focal laser for diabetic macular edema (DME), to examine real-world data regarding actual treatments patients are receiving, to present long-term visual outcomes in real-world practice, and to suggest an evidence-based approach for the use of focal laser.Methods:This study is a review of landmark studies evaluating focal laser and pharmacologic therapy for DME. In addition, the authors include a retrospective review of 102 consecutive eyes of 53 patients in our practice setting in rural Alabama. A chart review was performed, and patients were included if they were diagnosed with DME and were treated with both focal laser and bevacizumab. Bevacizumab and focal laser were given on a “as needed basis” at the discretion of one treating physician (J.O.M.). Worse visual acuity or worsening macular edema were indications for additional treatment. Statistical analysis was performed using frequencies and percentages. Best-corrected visual acuity (BCVA) was recorded at baseline and at the end of treatment (mean of 5 years) in the medical record. Primary outcome measures were BCVA, patients with better than 20/40 BCVA, patients with worse than 20/200 BCVA, and patients with stable BCVA.Results:Anti–vascular endothelial growth factor (VEGF) therapies are the first-line treatment for DME, but real-world claims data suggest that diabetic patients cannot come in for monthly injections as in large clinical trials. In our series, after a mean of 5 lasers and 5.5 injections, 90% of eyes had stable or better BCVA, 65% were ≥20/40, and only 13% were ≤20/200.Conclusions:Laser treatment for DME remains an important adjunctive therapy