Scholarlink

Introduction <p>Diabetic macular edema (DME) imposes a substantial clinical and psychosocial burden on patients and caregivers due to frequent visits and intravitreal treatments. The fluocinolone acetonide intravitreal implant (Iluvien<sup>®</sup>) offers sustained drug delivery for up to 3 years. We assessed its real-world impact on vision, macular anatomy, intraocular pressure (IOP), quality of life (QoL), and treatment burden, including caregiver impact.</p> Methods <p>Prospective, real-world observational study of 41 patients with previously treated DME. Assessments occurred at baseline and at 6, 12, 18, 24, and 30&#xa0;months. Outcomes included best-corrected visual acuity (BCVA), central macular thickness (CMT), IOP, and National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) composite scores. Burden metrics included clinic visits per year and caregiver accompaniment/absenteeism.</p> Results <p>At baseline, mean BCVA was 0.42 ± 0.30 logMAR, CMT 415.8 ± 106.5&#xa0;µm, IOP 16.6 ± 4.1&#xa0;mmHg, and NEI VFQ-25 67.6 ± 16.4; 46.3% of patients required caregiver accompaniment, and 61% reported pre-injection anxiety (median duration 2&#xa0;days). At last follow-up, mean BCVA improved to 0.29 ± 0.26 logMAR (≈+6–7 ETDRS letters; <i>p</i> &lt; 0.001), CMT decreased to 368.1 ± 79.6&#xa0;µm (<i>p</i> = 0.002), and IOP remained stable at 16.7 ± 4.1&#xa0;mmHg. The NEI VFQ-25 increased to 77.0 ± 18.0, with a significant main effect of time (repeated-measures analysis of variance (ANOVA), <i>p</i> = 0.001; partial <i>η</i><sup>2</sup> = 0.675); improvements were evident by 6&#xa0;months and sustained through 30&#xa0;months (all comparisons <i>p</i> &lt; 0.05). Clinic visits declined from 5.8 ± 1.6 to 3.7 ± 1.5 per year (<i>p</i> &lt; 0.001).</p> Conclusions <p>In a prospective real-world setting, Iluvien was associated with durable improvements in vision, macular anatomy, and QoL, with stable IOP. Treatment reduced the frequency of clinic visits and procedures, alleviating patient burden and caregiver absenteeism. These findings support Iluvien as a patient-centered, long-acting therapy for chronic DME and motivate multicenter validation and health-economic studies that incorporate caregiver outcomes.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Beyond Vision: Prospective Real-World Evaluation of Quality-of-Life and Caregiver Burden in Diabetic Macular Edema Treated with Fluocinolone Acetonide (Iluvien®)

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年11月14日

查看全文
  • João Alves-Ambrósio,
  • Pedro Cardoso Teixeira,
  • Mariana Garcia,
  • João Chibante-Pedro,
  • Miguel Ruão

摘要

Introduction

Diabetic macular edema (DME) imposes a substantial clinical and psychosocial burden on patients and caregivers due to frequent visits and intravitreal treatments. The fluocinolone acetonide intravitreal implant (Iluvien®) offers sustained drug delivery for up to 3 years. We assessed its real-world impact on vision, macular anatomy, intraocular pressure (IOP), quality of life (QoL), and treatment burden, including caregiver impact.

Methods

Prospective, real-world observational study of 41 patients with previously treated DME. Assessments occurred at baseline and at 6, 12, 18, 24, and 30 months. Outcomes included best-corrected visual acuity (BCVA), central macular thickness (CMT), IOP, and National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) composite scores. Burden metrics included clinic visits per year and caregiver accompaniment/absenteeism.

Results

At baseline, mean BCVA was 0.42 ± 0.30 logMAR, CMT 415.8 ± 106.5 µm, IOP 16.6 ± 4.1 mmHg, and NEI VFQ-25 67.6 ± 16.4; 46.3% of patients required caregiver accompaniment, and 61% reported pre-injection anxiety (median duration 2 days). At last follow-up, mean BCVA improved to 0.29 ± 0.26 logMAR (≈+6–7 ETDRS letters; p < 0.001), CMT decreased to 368.1 ± 79.6 µm (p = 0.002), and IOP remained stable at 16.7 ± 4.1 mmHg. The NEI VFQ-25 increased to 77.0 ± 18.0, with a significant main effect of time (repeated-measures analysis of variance (ANOVA), p = 0.001; partial η2 = 0.675); improvements were evident by 6 months and sustained through 30 months (all comparisons p < 0.05). Clinic visits declined from 5.8 ± 1.6 to 3.7 ± 1.5 per year (p < 0.001).

Conclusions

In a prospective real-world setting, Iluvien was associated with durable improvements in vision, macular anatomy, and QoL, with stable IOP. Treatment reduced the frequency of clinic visits and procedures, alleviating patient burden and caregiver absenteeism. These findings support Iluvien as a patient-centered, long-acting therapy for chronic DME and motivate multicenter validation and health-economic studies that incorporate caregiver outcomes.