Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases

Conditions
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Eye Abnormalities

Intervention / Treatment
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* Dietary Supplement: Complex product
* Dietary Supplement: Polyphenol-rich extracts
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complex product<br>18 volunteers | Dietary Supplement: Complex product<br>* 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<br>|
| Active Comparator: Polyphenol-rich extracts<br>18 volunteers | Dietary Supplement: Polyphenol-rich extracts<br>* Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules<br>|
| Placebo Comparator: Placebo<br>18 volunteers | Other: Placebo<br>* Single oral dose - 2 capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DEQS (Dry Eye-Related Quality-of-Life) index | Subjective symptom questionnaire assessment | Baseline, 6 weeks | 
| Visual Analogue Scale | Subjective symptom assessment | Baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical Coherence Tomography | An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease | Baseline, 6 weeks | 
| Amsler test | Amsler grid usually help detecting defects in central 20 degrees of the visual field | Baseline, 6 weeks | 
| Schirmer test, | Schirmer test quantitatively measures the tear production by the lacrimal gland | Baseline, 6 weeks | 
| Computerized Perimetry | Computerized Perimetry is used to evaluate visual function | Baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinal cells, Ocular diseases, Blue-light