Lutein Iontophoresis in Intermediate AMD and Reticular Pseudodrusen - a Retrospective Study (NCT07420361) | Clinical Trial Compass
CompletedNot Applicable
Lutein Iontophoresis in Intermediate AMD and Reticular Pseudodrusen - a Retrospective Study
Italy30 participantsStarted 2023-08-01
Plain-language 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.
Who can participate
Age range
55 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
functional parameter
Timeframe: August 2023 to August 2024
2
structural parameter over the course of follow-up
Timeframe: August 2023 to August 2024
3
structural parameter over the course of follow-up
Timeframe: August 2023 to August 2024
4
structural parameter over the course of follow-up
Timeframe: August 2023 to August 2024
5
structural parameter over the course of follow-up
Timeframe: August 2023 to August 2024
6
structural parameter over the course of follow-up
Timeframe: August 2023 to August 2024
7
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]