This is an observational study in which patients affected by dry or wet AMD will be enrolled, after signing the Informed Consent, according to eligibility criteria. Patients, after signing the Informed Consent, will enter into a screening phase during which the concomitant medication, clinical history, physical examination (including smoking habits) will be checked and the inclusion/exclusion criteria will be assessed. Then, at the time of Baseline visit (V0) the eligible patients will be given Visucomplex Plus as monotherapy, 1 capsule daily after food, or for dry or wet AMD patients under treatment with a stable dose of an anti-VEGF drug, Visucomplex Plus, 1 capsule daily after food, upon physical decision. Screening phase and the baseline visit (V0) could coincide.
Study Type
OBSERVATIONAL
Enrollment
160
capsule contains: Lutein, Zeaxanthin, alphalipoic acid MATRIX, Vitamine E, Zinc, Maquibright® (Aristotelian chilensis berry standardized, containing Anthocyanin and delphinidin extracts), Vitamin D and cupper.
Casa di Cura Villa dei Fiori
Acerra, Napoli, Italy
RECRUITINGOspedale Felice Lotti
Pontedera, Pisa, Italy
RECRUITINGASST Spedali Civili di Brescia
Brescia, Italy
NOT_YET_RECRUITINGOspedale Policlinico Casilino
Roma, Italy
RECRUITINGImprovement of QoL in patients affected by AMD (dry or wet) measured through a questionnaire self-administered by the patient partially derived from the VFQ-25, aiming to define a new assessment instrument coupled with the routinely clinical follow up.
QoL measured through a new questionnaire self-administered
Time frame: measured at baseline and after 4-8 and 12 months of treatment.
Comparison of improvement scoring of QoL between VFQ-25 and a newly conceived questionnaire
Comparison of improvement scoring of Quality of Life between the two questionnaires (VFQ-25 and a newly conceived one) at baseline and after 4-8 and 12 months of treatment. VFQ-25 is a valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ).
Time frame: measured at baseline and after 4-8 and 12 months of treatment.
Visual acuity
Evaluation of disease progression through Visual acuity.
Time frame: measured at baseline and after 4-8 and 12 months of treatment.
OCT
Evaluation of disease progression through Optical Coherence Tomography (OCT).
Time frame: measured at baseline and at the end of the observation period (12 months).
Questionnaire completion compliance
Evaluation of improvement of completion compliance of the new questionnaire versus standard of care one (VFQ-25). VFQ-25 is a valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ).
Time frame: measured at the end of the observation period (12 months).
Likert scales (5 points)
Evaluation of Patient's treatment judgement and improvement of condition (Likert Scales). A Likert scale is a rating scale where patients have to indicate their treatment judgement and improvement of condition crossing a score from 1 to 5.
Time frame: measured at baseline and after 4-8 and 12 months of treatment.
subject and investigator satisfaction: questionnaire
Evaluation of subject and investigator satisfaction of the new questionnaire. Subject and investigator satisfaction is to be indicated on a scale crossing a score from 1 to 5.
Time frame: measured at baseline and after 4-8 and 12 months of treatment.
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