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

OBJECTIVES

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.

METHODS

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).

RESULTS

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.

CONCLUSIONS

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.