Eye Abnormalities
Conditions
Keywords
Retinal cells, Ocular diseases, Blue-light
Brief summary
The aim of the study is to confirm that daily supplementation with a product containing a standardized combination of polyphenol-rich extracts has a protective effect against potential blue-light-induced damage to retinal cells.
Detailed description
Randomized, double-blind, parallel study conducted under medical supervision on a group of 54 volunteers exposed to blue-light for 6-8h a day. Patients receive one of the investigational products or placebo for 6 weeks. Study parameters: OCT (optical coherence tomography), Amsler test, Computerized Perimetry, Schirmer test. In addition, subjective symptoms will be assessed using the Visual Analog Scale (VAS) method and a Dry Eye-Related Quality-of-Life Questionnaire. The studied parameters will be measured before and after supplementation.
Interventions
DIETARY_SUPPLEMENTComplex product
Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica, rutin, vitamin B6, vitamin B12, folic acid Single oral dose - 2 capsules
DIETARY_SUPPLEMENTPolyphenol-rich extracts
Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules
OTHERPlacebo
Single oral dose - 2 capsules
Sponsors
AronPharma Sp. z o. o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women and men, 25-45 years old. * Signed informed consent. * Volunteers who do not use glasses or contact lenses. * Volunteers exposed to blue light for at least 6 - 8 hours a day.
Exclusion criteria
* Intake of supplements containing plant extracts, polyphenols or anthocyanins. * Participation in another clinical trial. * Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study. * Women who are pregnant, planning to become pregnant during the study, or breastfeeding. * Use of drugs that cause impaired vision or impaired tear secretion (including digoxin, fluoroquinolones, metronidazole, hydrochlorothiazide, retinoids). * Current use of eye drops in the treatment of ocular diseases. * Ocular diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DEQS (Dry Eye-Related Quality-of-Life) index | Baseline, 6 weeks | Subjective symptom questionnaire assessment |
| Visual Analogue Scale | Baseline, 6 weeks | Subjective symptom assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optical Coherence Tomography | Baseline, 6 weeks | An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease |
| Amsler test | Baseline, 6 weeks | Amsler grid usually help detecting defects in central 20 degrees of the visual field |
| Schirmer test, | Baseline, 6 weeks | Schirmer test quantitatively measures the tear production by the lacrimal gland |
| Computerized Perimetry | Baseline, 6 weeks | Computerized Perimetry is used to evaluate visual function |
Countries
Poland
Outcome results
None listed