About this trial
The proposed clinical investigation wants primary to validate the safety of the innovative light therapy approach and in second priority provide insight and confirmations on therapeutic effect.
By combining two clinically standard laser-light treatment, both exhibiting a solid-safe profile: the photothermal and the photobiological techniques; the investigational device (reSEES) wants to explore a completely new therapeutic approach by synergically take advantage of the inherent and already observed clinical performances of the two independent techniques.
Eligibility criteria
Qualifiers
Male and female patients ≥ 50 years of age
Intermediate AMD, Grade AREDS 3
Both eyes eligible for the study Patients willing to enrol in a clinical study must sign a written informed consent form, cooperate with protocols, and comply with follow-up.
Dietary supplements and life-style habits must remain unchanged, as far as possible, for the duration of investigation participation.
Disqualifiers
Myopia > 8D
Maximum pupillary aperture ᴓ4mm with medical dilation
Anticipation of ocular surgery during the study
Clinically significative cataract
Trial design
Treatments tested in this trial
- reSEES
Treatment groups
Sponsors and collaborators
Oculox Technologies SA
Lead sponsor
Latis S.r.l.
Collaborator