PresbyopiaNCT07382882
The Effect of Orally Administered Extracts of Chokeberry, Kamchatka Berry and Blueberry on the Condition of the Eye.
A study testing AKB in people with Presbyopia, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- AKB
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 sitePoland
- Study dates
- 3 Nov 2022to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wpływ Podawanego Doustnie Ekstraktu z Aronii, Jagody Kamczackiej Oraz Czarnej Jagody na Stan narządu Wzroku.
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.
Read the detailed description
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.
- Conditions
- Presbyopia
- Being tested
- AKB, Placebo
- Keywords
- Presbyopia, iridoids, anthocyanins, chokeberry, blueberry, honeysuckle berry
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKBDietary supplement
Standardized berry extract (Aronia melanocarpa, Lonicera caerulea, Vaccinium myrtillus), 400 mg capsule, BID, 6 weeks
PlaceboOther
Matching placebo capsules (maltodextrin + colouring), BID, 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1: Dietary Supplement: AKB | Experimental | dose: 400 mg capsule, 1 capsule BID (2×/d) throug 6 weeks Receives: Dietary Supplement: AKB |
| Intervention 2: Placebo | Placebo comparator | maltodextrin + natural caramel colouring, BID, 6 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and Week 6.
Change in OCT / OCT-angiography parameters
Change from baseline in RNFL thickness (µm) measured by spectral-domain OCT.
Measured: Baseline and Week 6.
Change in OCT / OCT-angiography parameters
Change from baseline in central macular thickness (µm) measured by spectral-domain OCT.
Measured: Baseline and Week 6.
Change in OCT / OCT-angiography parameters
Change from baseline in GCC thickness (µm) measured by spectral-domain OCT.
Measured: Baseline and Week 6.
Change in OCT / OCT-angiography parameters
Change from baseline in retinal vessel density (%) measured by OCT-angiography.
Measured: Baseline and Week 6.
Secondary outcomes (3)
Change in serum CRYAA concentration
Change from baseline in serum CRYAA concentration measured by ELISA (ng/mL).
Measured: One month.
Change in serum CRYAB concentration
Change from baseline in serum CRYAB concentration measured by ELISA (ng/mL).
Measured: one month
Change in serum TRPV4 level
Change from baseline in serum TRPV4 level measured by ELISA (ng/mL).
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start3 Nov 2022
- Primary completion7 Mar 2023
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomised, double-blind, placebo-controlled, two-period crossover trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorota Szumny, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382882
- Sponsor's protocol ID
- KB 672/2022, KB 258/2025
- Other IDs
- SUBZ.A080.22.076 and Subz.A080
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wpływ Podawanego Doustnie Ekstraktu z Aronii, Jagody Kamczackiej Oraz Czarnej Jagody na Stan narządu Wzroku.
- ClinicalTrials.gov ID
- NCT07382882
- Acronym / sponsor ID
- KB 672/2022, KB 258/2025
- Conditions
- Presbyopia
- Keywords
- Presbyopia, iridoids, anthocyanins, chokeberry, blueberry, honeysuckle berry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomised, double-blind, placebo-controlled, two-period crossover trial
| Arm | Type | Receives |
|---|---|---|
| Intervention 1: Dietary Supplement: AKB | Experimental | Dietary Supplement: AKBdose: 400 mg capsule, 1 capsule BID (2×/d) throug 6 weeks |
| Intervention 2: Placebo | Placebo comparator | Other: Placebomaltodextrin + natural caramel colouring, BID, 6 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- Age < 50 years.
- History of ocular surgery within 12 months prior to enrollment.
- Macular degeneration
- Diabetic retinopathy
- Retinal vein occlusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKBStandardized berry extract (Aronia melanocarpa, Lonicera caerulea, Vaccinium myrtillus), 400 mg capsule, BID, 6 weeks | Dietary supplement | Intervention 1: Dietary Supplement: AKB |
| PlaceboMatching placebo capsules (maltodextrin + colouring), BID, 6 weeks | Other | Intervention 2: Placebo |
Primary outcome
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.
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).
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).
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).
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).
Change in OCT / OCT-angiography parameters
Time frame: Baseline and Week 6.
Change from baseline in RNFL thickness (µm) measured by spectral-domain OCT.
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.
Change in OCT / OCT-angiography parameters
Time frame: Baseline and Week 6.
Change from baseline in GCC thickness (µm) measured by spectral-domain OCT.
Change in OCT / OCT-angiography parameters
Time frame: Baseline and Week 6.
Change from baseline in retinal vessel density (%) measured by OCT-angiography.
3 secondary outcomes
Change in serum CRYAA concentration
Time frame: One month.
Change in serum CRYAB concentration
Time frame: one month
Change in serum TRPV4 level
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKB in people with Presbyopia, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual field (automated perimetry) (time frame: Baseline and Week 6.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.