Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Complex product 18 volunteers |
Dietary Supplement: Complex 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
|
| Active Comparator: Polyphenol-rich extracts 18 volunteers |
Dietary Supplement: Polyphenol-rich extracts
Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules
|
| Placebo Comparator: Placebo 18 volunteers |
Other: Placebo
Single oral dose - 2 capsules
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women and men, 25-45 years old.
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Signed informed consent.
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Volunteers who do not use glasses or contact lenses.
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Volunteers exposed to blue light for at least 6 - 8 hours a day.
Exclusion Criteria:
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Intake of supplements containing plant extracts, polyphenols or anthocyanins.
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Participation in another clinical trial.
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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.
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Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
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Use of drugs that cause impaired vision or impaired tear secretion (including digoxin, fluoroquinolones, metronidazole, hydrochlorothiazide, retinoids).
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Current use of eye drops in the treatment of ocular diseases.
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Ocular diseases.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centrum Zdrowia Eter-Med sp. z o.o. | Gdańsk | Poland | 80-822 |
Sponsors and Collaborators
- AronPharma Sp. z o. o.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05-AP-RET