Actively Recruiting
Lutein by Scleral Iontophoresis in AMD
Led by Federico II University · Updated on 2025-04-13
80
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of the clinical investigation is to evaluate the performance, safety and degree of tolerability resulting from the use of the iontophoresis medical device in adult subjects diagnosed with AMD stage 3 (AREDS classification) in one or both eyes.
CONDITIONS
Official Title
Lutein by Scleral Iontophoresis in AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 years or older
- Able to provide informed consent
- Diagnosed with age-related macular degeneration (AMD) category 3 in one or both eyes based on AREDS criteria
- In good general health
- Spherical equivalent refraction between +4.0 and -4.0 diopters
- Best corrected visual acuity (BCVA) for glasses 0.1 LogMAR or better
- Intraocular pressure (IOP) of 20 mmHg or less
- Able to cooperate with the investigator and meet all study requirements
- Qualify for treatment with Iontoretina according to approved indications
You will not qualify if you...
- Eye surgery or invasive eye treatments within 3 months before the study on the study eye
- Eye lesions, scars, or abrasions in the study eye
- Dense opacities of ocular components in the study eye
- Intraocular lens implantation in the study eye
- Congenital malformations in the study eye
- History of ocular hypertension, glaucoma, macular pucker, optic neuropathy, diabetic retinopathy, dry eye syndrome in the study eye
- Use of lutein, zeaxanthin, or other eye health supplements within 4 weeks before screening
- Known allergy or hypersensitivity to device components or related substances
- Type I diabetes or previous stroke
- Uncontrolled hypertension or heart disease preventing study participation
- Smoking more than 20 cigarettes per day
- Drinking more than 2 alcoholic drinks per day
- Women of childbearing potential who are pregnant, intend to become pregnant during the study, or on hormone replacement therapy for menopause
- Participation in another clinical study within 90 days
- Unable to follow study procedures and attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Federico II University
Naples, Italy, 80100
Actively Recruiting
Research Team
C
Ciro Costagliola, Director Of Ophthalmology Unit
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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