Lutein Iontophoresis in Intermediate AMD and Reticular Pseudodrusen - a Retrospective Study

Short-term Efficacy and Safety of Transcleral Lutein Iontophoresis in Patients With Intermediate Amd and Reticular Pseudodrusen: a Retrospective Study

There is limited data available on the efficacy and safety of Transscleral Lutein Iontophoresis (TSLI) in patients with in-termediate age-related macular degeneration (iAMD) and reticular pseudodrusen (RPD).

This retrospective multicentre study evaluated the functional and morphological outcomes of TSLI in patients with stage 2 and stage 3 iAMD with RPD. Autofluorescence (AF), Optical Coherence Tomography (OCT), Best Corrected Visual Acuity (BCVA), Intraocular Pressure (IOP), Macular Sensitivity (MS) and adverse events, were recorded at baseline, 1 month and 3 months follow-up after treatment.

Study Overview

• Status: Completed
• Conditions: Intermediate Age-Related Macular Degeneration With Reticular Pseudodrusen

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy
    • Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients from the regions of Naples and Cagliari

Description

Inclusion criteria

• Age between 55 and 80 years old
• diagnosis of early to intermediate stage dAMD (based on AREDS criteria)
• presence of RPD
• Treated with scleral Lutein Iontophoresis

Exclusion Criteria:

• GA or MNV in the included eye
• any prior or any ongoing medical or surgical treatment of the included eye (including intravitreal injections, oral supplementation of lutein, zeaxanthin and or high dietary intake of antioxidants)
• smokers (consummation of more than 20 cigarettes per day)
• history of treatment with drugs with a well-known possible ophthalmic side-effect
• known eye diseases such glaucoma, acute or chronic uveitis, advanced cataract, stage 4 dry eye disease or any opacities of the ocular media that do not permit high-quality imaging examinations
• manifest refraction outside of -6 and +4 dioptres
• BCVA < 40 EDTRS letters.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
transcleral lutein iontophoresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional parameter	best corrected visual acuity (logMar)	August 2023 to August 2024
structural parameter over the course of follow-up	Outer retinal morphology using OCT and changes in FAF, specifically RPD type (1-4)	August 2023 to August 2024
structural parameter over the course of follow-up	Outer retinal morphology using OCT and changes in FAF, specifically ONL thickness (micrometers)	August 2023 to August 2024
structural parameter over the course of follow-up	Outer retinal morphology using OCT and changes in FAF, specifically choroidal thickness (micrometers)	August 2023 to August 2024
structural parameter over the course of follow-up	Outer retinal morphology using OCT and changes in FAF, specifically CMT (micrometers)	August 2023 to August 2024
structural parameter over the course of follow-up	changes in FAF, (descriptive - iso/hyper/hypofluorescent)	August 2023 to August 2024
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	monitoring of adverse events over the course of the follow up (n)	August 2023 to August 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional parameter	mean sensitivity (dB)	August 2023 to August 2024

Collaborators and Investigators

• Sponsor: Mario Damiano Toro

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: age related macular degeneration; transcleral lutein iontophoresis; reticular pseudodrusen
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration
• Other Study ID Numbers: 273/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No