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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complex product | Experimental | 18 volunteers |
|
| Polyphenol-rich extracts | Active Comparator | 18 volunteers |
|
| Placebo | Placebo Comparator | 18 volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complex product | Dietary Supplement | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centrum Zdrowia Eter-Med sp. z o.o. | Gdansk | 80-822 | Poland |
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| Polyphenol-rich extracts | Dietary Supplement | Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules |
|
| Placebo | Other | Single oral dose - 2 capsules |
|
| 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 |
| ID | Term |
|---|---|
| D005124 | Eye Abnormalities |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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