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

Not Applicable

Completed

• Conditions: Eye Abnormalities
• Interventions: Other: Placebo; Dietary Supplement: Polyphenol-rich extracts; Dietary Supplement: Complex product

• Registration Number: NCT06004570
• Lead Sponsor: AronPharma Sp. z o. o.

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 Timeline

• Study Start: 2023-06-15
• Status Verified: 2023-08
• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-22
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	18 volunteers
Polyphenol-rich extracts	Polyphenol-rich extracts	18 volunteers
Complex product	Complex product	18 volunteers

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Optical Coherence Tomography	Baseline, 6 weeks	An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease
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
Amsler test	Baseline, 6 weeks	Amsler grid usually help detecting defects in central 20 degrees of the visual field

Trial Locations

Locations (1)

Centrum Zdrowia Eter-Med sp. z o.o.; 🇵🇱 Gdańsk, Poland