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

NCT07382882 | Completed

• 2 other identifiers: KB 672/2022, KB 258/2025SUBZ.A080.22.076 and Subz.A080
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Presbyopia

Keywords

Presbyopia; iridoids; anthocyanins; chokeberry; blueberry; honeysuckle berry

Outcome Measures

Primary Outcomes (9)

• Change in visual field (automated perimetry)

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

  Baseline and Week 6.

• Change in PVEP P100 latency (pattern size 1.0)

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

  Baseline and Week 6.

• Change in PVEP P100 amplitude (pattern size 1.0)

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

  Baseline and Week 6.

• Change in PVEP P100 latency (pattern size 0.3)

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

  Baseline and Week 6.

• Change in PVEP P100 amplitude (pattern size 0.3)

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

  Baseline and Week 6.

• Change in OCT / OCT-angiography parameters

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

  Baseline and Week 6.

• Change in OCT / OCT-angiography parameters

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

  Baseline and Week 6.

• Change in OCT / OCT-angiography parameters

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

  Baseline and Week 6.

• Change in OCT / OCT-angiography parameters

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

  Baseline and Week 6.

Secondary Outcomes (3)

• Change in serum CRYAA concentration

  One month.

• Change in serum CRYAB concentration

  one month

• Change in serum TRPV4 level

  one month

Study Arms (2)

Intervention 1: Dietary Supplement: AKB

EXPERIMENTAL

dose: 400 mg capsule, 1 capsule BID (2×/d) throug 6 weeks

Dietary Supplement: AKB

Intervention 2: Placebo

PLACEBO COMPARATOR

maltodextrin + natural caramel colouring, BID, 6 weeks

Other: Placebo

Interventions

AKB DIETARY_SUPPLEMENT

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

Intervention 1: Dietary Supplement: AKB

Placebo OTHER

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

Intervention 2: Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, 50-367, Poland

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomised, double-blind, placebo-controlled, two-period crossover trial

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 3, 2026
• Study Start: November 3, 2022
• Primary Completion: March 7, 2023
• Study Completion: August 15, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

PL (1)