NCT07420361Completed
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
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 30 (actual)
- First submitted
- 1 Feb 2026
- Start date
- 1 Aug 2023
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Mario Damiano Toro
- Diseases
- Macular degeneration
- NCT number
- NCT07420361
What you commit to
- Study type: Observational
- Participants enrolled: 30
- From 1 Aug 2023 to the primary completion date, 31 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- history of treatment with drugs with a well-known possible ophthalmic side-effect
Other illness
- 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
Other
- GA or MNV in the included eye
- smokers (consummation of more than 20 cigarettes per day)
- manifest refraction outside of -6 and +4 dioptres
- BCVA \< 40 EDTRS letters.
Who the study is looking for
- 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
Age in the registry: 55 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.