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Completed

NCT Number: NCT07420361

Lutein Iontophoresis in 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.

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Key information

Conditions

Intermediate Age-Related Macular Degeneration With Reticular Pseudodrusen Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federico II

Naples, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. functional parameter

    Time frame: August 2023 to August 2024

    best corrected visual acuity (logMar)

  2. structural parameter over the course of follow-up

    Time frame: August 2023 to August 2024

    Outer retinal morphology using OCT and changes in FAF, specifically RPD type (1-4)

  3. structural parameter over the course of follow-up

    Time frame: August 2023 to August 2024

    Outer retinal morphology using OCT and changes in FAF, specifically ONL thickness (micrometers)

  4. structural parameter over the course of follow-up

    Time frame: August 2023 to August 2024

    Outer retinal morphology using OCT and changes in FAF, specifically choroidal thickness (micrometers)

  5. structural parameter over the course of follow-up

    Time frame: August 2023 to August 2024

    Outer retinal morphology using OCT and changes in FAF, specifically CMT (micrometers)

  6. structural parameter over the course of follow-up

    Time frame: August 2023 to August 2024

    changes in FAF, (descriptive - iso/hyper/hypofluorescent)

  7. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: August 2023 to August 2024

    monitoring of adverse events over the course of the follow up (n)

Secondary outcomes

  1. functional parameter

    Time frame: August 2023 to August 2024

    mean sensitivity (dB)

Sponsors and collaborators

Lead sponsor

Mario Damiano Toro

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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