PDF(Pubmed)
Abstract：
UNASSIGNED: Diabetes is associated with ocular complications including diabetic macular edema (DME). Current therapies are invasive and include repeated intravitreal injections and laser therapy. Photobiomodulation (PBM) is a treatment (Tx) that utilizes selected wavelengths of light to induce cellular benefits including reduction of inflammation and edema. This single-center, open-label, post-hoc analysis explored the utility of multiwavelength PBM in subjects with DME.
UNASSIGNED: Analysis included review of data from patients undergoing standard clinical care with an approved and marketed PBM medical device, the Valeda® Light Delivery System. Subjects with early-stage DME with good vision (Best-corrected visual acuity (BCVA) > 20/25, logMAR > 0.1) were evaluated in clinic and treated with one series of multiwavelength PBM (Tx delivered 3x/week over 3-4 weeks; total of 9 Tx sessions). Clinical, anatomical, and safety parameters were assessed in addition to subjective quality of life.
UNASSIGNED: A total of 30 eyes (19 subjects) were analyzed. Subjects were predominately male (68.4%) with a mean age of 56 ± 14 years. Reductions in central retinal thickness (CRT), resolution of intraretinal fluid (IRF) and improvement in diabetic retinopathy severity scale scores were observed following PBM treatment in select patients. Baseline BCVA remained stable over the follow-up observation period of 3 months post-PBM. Approximately 64% of patients reported subjective improvements in their ocular condition and decreased influence in everyday life. Detailed OCT evaluations confirmed no safety issues related to phototoxicity up to 16 months.
UNASSIGNED: Early-stage DME subjects treated with Valeda multiwavelength PBM showed improvements in clinical and anatomical parameters. The Valeda multiwavelength PBM approach demonstrates a favorable safety profile with no signs of phototoxicity following an independent OCT review. PBM therapy may offer an alternative, non-invasive treatment strategy with a unique mechanism and modality for patients with early-stage DME.
UNASSIGNED: Analysis included review of data from patients undergoing standard clinical care with an approved and marketed PBM medical device, the Valeda® Light Delivery System. Subjects with early-stage DME with good vision (Best-corrected visual acuity (BCVA) > 20/25, logMAR > 0.1) were evaluated in clinic and treated with one series of multiwavelength PBM (Tx delivered 3x/week over 3-4 weeks; total of 9 Tx sessions). Clinical, anatomical, and safety parameters were assessed in addition to subjective quality of life.
UNASSIGNED: A total of 30 eyes (19 subjects) were analyzed. Subjects were predominately male (68.4%) with a mean age of 56 ± 14 years. Reductions in central retinal thickness (CRT), resolution of intraretinal fluid (IRF) and improvement in diabetic retinopathy severity scale scores were observed following PBM treatment in select patients. Baseline BCVA remained stable over the follow-up observation period of 3 months post-PBM. Approximately 64% of patients reported subjective improvements in their ocular condition and decreased influence in everyday life. Detailed OCT evaluations confirmed no safety issues related to phototoxicity up to 16 months.
UNASSIGNED: Early-stage DME subjects treated with Valeda multiwavelength PBM showed improvements in clinical and anatomical parameters. The Valeda multiwavelength PBM approach demonstrates a favorable safety profile with no signs of phototoxicity following an independent OCT review. PBM therapy may offer an alternative, non-invasive treatment strategy with a unique mechanism and modality for patients with early-stage DME.
摘要：
糖尿病与包括糖尿病性黄斑水肿(DME)在内的眼部并发症有关。目前的疗法是侵入性的并且包括重复的玻璃体内注射和激光治疗。光生物调节(PBM)是一种利用选定波长的光来诱导细胞益处(包括减少炎症和水肿)的治疗(Tx)。这个单一中心，开放标签，事后分析探索了多波长PBM在DME受试者中的实用性。
分析包括对使用已批准和上市的PBM医疗器械进行标准临床护理的患者的数据进行审查，Valeda®轻型运输系统。在临床上评估了具有良好视力的早期DME（最佳矫正视力（BCVA）>20/25，logMAR>0.1）的受试者，并使用一系列多波长PBM进行治疗（在3-4周内每周进行3次Tx治疗；总共9次Tx治疗）。临床,解剖学,除主观生活质量外,还评估了安全性参数.
■总共分析了30只眼(19名受试者)。受试者主要为男性（68.4％），平均年龄为56±14岁。减少中央视网膜厚度（CRT），部分患者接受PBM治疗后,观察到视网膜内液体(IRF)的消退和糖尿病视网膜病变严重程度量表评分的改善.基线BCVA在PBM后3个月的随访观察期内保持稳定。大约64％的患者报告了他们的眼部状况的主观改善和日常生活中的影响减少。详细的OCT评估证实在长达16个月的时间内没有与光毒性相关的安全性问题。
■接受Valeda多波长PBM治疗的早期DME受试者在临床和解剖学参数方面表现出改善。Valeda多波长PBM方法在独立OCT审查后显示出良好的安全性，没有光毒性迹象。PBM治疗可能提供另一种选择，早期DME患者的非侵入性治疗策略具有独特的机制和方式。
分析包括对使用已批准和上市的PBM医疗器械进行标准临床护理的患者的数据进行审查，Valeda®轻型运输系统。在临床上评估了具有良好视力的早期DME（最佳矫正视力（BCVA）>20/25，logMAR>0.1）的受试者，并使用一系列多波长PBM进行治疗（在3-4周内每周进行3次Tx治疗；总共9次Tx治疗）。临床,解剖学,除主观生活质量外,还评估了安全性参数.
■总共分析了30只眼(19名受试者)。受试者主要为男性（68.4％），平均年龄为56±14岁。减少中央视网膜厚度（CRT），部分患者接受PBM治疗后,观察到视网膜内液体(IRF)的消退和糖尿病视网膜病变严重程度量表评分的改善.基线BCVA在PBM后3个月的随访观察期内保持稳定。大约64％的患者报告了他们的眼部状况的主观改善和日常生活中的影响减少。详细的OCT评估证实在长达16个月的时间内没有与光毒性相关的安全性问题。
■接受Valeda多波长PBM治疗的早期DME受试者在临床和解剖学参数方面表现出改善。Valeda多波长PBM方法在独立OCT审查后显示出良好的安全性，没有光毒性迹象。PBM治疗可能提供另一种选择，早期DME患者的非侵入性治疗策略具有独特的机制和方式。
