Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AronPharma Sp. z o. o.
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- DEQS (Dry Eye-Related Quality-of-Life) index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Complex product
18 volunteers
Intervention: Complex product (Dietary Supplement)
Polyphenol-rich extracts
18 volunteers
Intervention: Polyphenol-rich extracts (Dietary Supplement)
Placebo
18 volunteers
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
DEQS (Dry Eye-Related Quality-of-Life) index
Time Frame: Baseline, 6 weeks
Subjective symptom questionnaire assessment
Visual Analogue Scale
Time Frame: Baseline, 6 weeks
Subjective symptom assessment
Secondary Outcomes
- Computerized Perimetry(Baseline, 6 weeks)
- Optical Coherence Tomography(Baseline, 6 weeks)
- Schirmer test,(Baseline, 6 weeks)
- Amsler test(Baseline, 6 weeks)