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Completed

NCT Number: NCT07382882

The Effect of Orally Administered Extracts of Chokeberry, Kamchatka Berry and Blueberry on the Condition of the Eye.

This study evaluated whether a standardized berry-extract dietary supplement (AKB; Aronia melanocarpa, Lonicera caerulea, Vaccinium myrtillus) improves visual function in adults with presbyopia. In a randomized, double-blind, placebo-controlled two-period crossover design, participants received AKB 400 mg twice daily and placebo for 6 weeks each, separated by a 5-week washout. Visual function and retinal/neuronal measures were assessed with contrast sensitivity testing, visual fields, VEP, and OCT/AngioOCT. Serum biomarkers related to lens and retinal physiology were also measured.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wroclaw Medical University

Wroclaw, 50-367, Poland

About this study

Participants were randomized to one of two sequences (AKB→placebo or placebo→AKB). Each treatment period lasted 6 weeks, separated by a 5-week washout. Ophthalmological assessments were performed at baseline and during the final week of each treatment period. The primary analysis compared within-participant changes after AKB versus placebo.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 50 years.

Clinical diagnosis of presbyopia.

Best-corrected visual acuity (BCVA) ≥ 20/40.

Spherical refraction between -3.0 and +3.0 diopters (D).

Cylinder correction ≤ ±3.0 D.

Exclusion criteria

Age < 50 years.

History of ocular surgery within 12 months prior to enrollment.

Presence of ocular diseases/conditions that may affect outcomes, including:

Macular degeneration

Diabetic retinopathy

Retinal vein occlusion

Glaucoma

Other significant acquired or hereditary eye conditions

Neurological disorders affecting visual fields.

Refractive error outside eligibility limits:

Spherical refraction < -3.0 D or > +3.0 D

Cylinder correction > ±3.0 D

Systemic conditions that may influence optic nerve head perfusion, including:

Hypotension

Severe circulatory failure

Vascular endothelial disorders

Gastrointestinal conditions, including:

Hyperacidity

Peptic ulcer disease

Treatment and study plan

AKB

Dietary Supplement

Standardized berry extract (Aronia melanocarpa, Lonicera caerulea, Vaccinium myrtillus), 400 mg capsule, BID, 6 weeks

Placebo

Other

Matching placebo capsules (maltodextrin + colouring), BID, 6 weeks

Primary outcomes

  1. Change in visual field (automated perimetry)

    Time frame: Baseline and Week 6.

    Change from baseline in visual field mean deviation (MD, dB) measured by standard automated perimetry measured by Humphrey Field Analyzer.

  2. Change in PVEP P100 latency (pattern size 1.0)

    Time frame: Baseline and Week 6.

    Change from baseline to Week 6 in PVEP P100 latency (ms) measured by pattern-reversal VEP (pattern size 1.0).

  3. Change in PVEP P100 amplitude (pattern size 1.0)

    Time frame: Baseline and Week 6.

    Change from baseline to Week 6 in PVEP P100 amplitude (µV) measured by pattern-reversal VEP (pattern size 1.0).

  4. Change in PVEP P100 latency (pattern size 0.3)

    Time frame: Baseline and Week 6.

    Change from baseline to Week 6 in PVEP P100 latency (ms) measured by pattern-reversal VEP (pattern size 0.3).

  5. Change in PVEP P100 amplitude (pattern size 0.3)

    Time frame: Baseline and Week 6.

    Change from baseline to Week 6 in PVEP P100 amplitude (µV) measured by pattern-reversal VEP (pattern size 0.3).

  6. Change in OCT / OCT-angiography parameters

    Time frame: Baseline and Week 6.

    Change from baseline in RNFL thickness (µm) measured by spectral-domain OCT.

  7. Change in OCT / OCT-angiography parameters

    Time frame: Baseline and Week 6.

    Change from baseline in central macular thickness (µm) measured by spectral-domain OCT.

  8. Change in OCT / OCT-angiography parameters

    Time frame: Baseline and Week 6.

    Change from baseline in GCC thickness (µm) measured by spectral-domain OCT.

  9. Change in OCT / OCT-angiography parameters

    Time frame: Baseline and Week 6.

    Change from baseline in retinal vessel density (%) measured by OCT-angiography.

Secondary outcomes

  1. Change in serum CRYAA concentration

    Time frame: One month.

    Change from baseline in serum CRYAA concentration measured by ELISA (ng/mL).

  2. Change in serum CRYAB concentration

    Time frame: one month

    Change from baseline in serum CRYAB concentration measured by ELISA (ng/mL).

  3. Change in serum TRPV4 level

    Time frame: one month

    Change from baseline in serum TRPV4 level measured by ELISA (ng/mL).

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

Wpływ Podawanego Doustnie Ekstraktu z Aronii, Jagody Kamczackiej Oraz Czarnej Jagody na Stan narządu Wzroku.

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Feb 3, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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