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

AronPharma

Status: Completed

Conditions: Eye Abnormalities

Treatments: Other: Placebo; Dietary Supplement: Polyphenol-rich extracts; Dietary Supplement: Complex product

Study type: Interventional

Funder types: Industry

Identifiers

NCT06004570

05-AP-RET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 3 patient groups, including a placebo group

Complex product

Experimental group

Description:

18 volunteers

Treatment:

Dietary Supplement: Complex product

Polyphenol-rich extracts

Active Comparator group

Description:

18 volunteers

Treatment:

Dietary Supplement: Polyphenol-rich extracts

Placebo

Placebo Comparator group

Description:

18 volunteers

Treatment:

Other: Placebo