Scleral iontophoresis for targeted lutein delivery in intermediate stage dry AMD: Is this a new frontier in age macular degeneration?

• Age-related macular degeneration (AMD) is a leading cause of vision impairment, with no effective treatments for intermediate stage of AMD or geographic atrophy, highlighting the need for novel therapeutic approaches. Oral lutein supplementation has demonstrated benefits in AMD but is constrained by poor bioavailability and inconsistent retinal delivery. • This study investigated whether scleral iontophoresis could enhance lutein delivery to the macula, improve macular pigment optical density (MPOD), and provide functional benefits in patients with intermediate stage of AMD. • After six months, lutein delivery via scleral iontophoresis significantly increased MPOD and improved microperimetry parameters, including mean sensitivity and fixation stability, but did not lead to a statistically significant improvement in visual acuity. • The findings suggest that targeted lutein delivery may offer functional benefits by enhancing retinal sensitivity, even if visual acuity remains unchanged, supporting the role of early MPOD enhancement in AMD management. • While promising, further research with larger cohorts and longer follow-up is needed to confirm the clinical efficacy of scleral iontophoresis and its potential role in AMD treatment strategies. To evaluate the retinal morphofunctional changes in patients with stage 2 age-related macular degeneration (AMD) following scleral iontophoresis for lutein delivery, and to assess its safety. In this prospective, non-randomized, single-arm pilot study, 30 stage 2 AMD patients (mean age 71.6 ± 10.88 years) received scleral iontophoresis with a liquid lutein formulation. Comprehensive ophthalmologic assessments—including best-corrected visual acuity (BCVA), macular pigment optical density (MPOD) via one-wavelength reflectometry, and microperimetry (mean sensitivity, mean defect, and fixation stability measured as BCEA)—were performed at baseline and at 6 months. Adverse events were monitored, and ocular surface health was assessed using the Ocular Surface Disease Index (OSDI). At 6 months, MPOD significantly increased from 0.169 ± 0.06 to 0.180 ± 0.075 density units (p = 0.0313). Mean sensitivity improved from 7.26 ± 5.13 dB to 8.18 ± 4.57 dB (p = 0.0179), and mean defect improved from –11.48 ± 4.90 dB to –10.27 ± 3.76 dB (p = 0.0207). Fixation stability, as measured by BCEA at 3 standard deviations, significantly decreased (p = 0.0107). No significant change was observed in BCVA, and OSDI scores remained stable. No adverse events were reported. Scleral iontophoresis of lutein is a safe and promising technique to enhance local MPOD and retinal sensitivity in intermediate AMD patients. Further studies with larger cohorts are warranted to confirm these preliminary findings.