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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07420361

Enrollment

Registered

2026-02-19

Start date

2023-08-01

Completion date

2024-08-31

Last updated

2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermediate Age-Related Macular Degeneration With Reticular Pseudodrusen

Keywords

transcleral lutein iontophoresis, age related macular degeneration, reticular pseudodrusen

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

55 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results