- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07382882
The Effect of Orally Administered Extracts of Chokeberry, Kamchatka Berry and Blueberry on the Condition of the Eye.
Wpływ Podawanego Doustnie Ekstraktu z Aronii, Jagody Kamczackiej Oraz Czarnej Jagody na Stan narządu Wzroku.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Wroclaw, Poland, 50-367
- Wroclaw Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention 1: Dietary Supplement: AKB
dose: 400 mg capsule, 1 capsule BID (2×/d) throug 6 weeks
|
Standardized berry extract (Aronia melanocarpa, Lonicera caerulea, Vaccinium myrtillus), 400 mg capsule, BID, 6 weeks
|
|
Placebo Comparator: Intervention 2: Placebo
maltodextrin + natural caramel colouring, BID, 6 weeks
|
Matching placebo capsules (maltodextrin + colouring), BID, 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and Week 6.
|
|
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).
|
Baseline and Week 6.
|
|
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).
|
Baseline and Week 6.
|
|
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).
|
Baseline and Week 6.
|
|
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).
|
Baseline and Week 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.
|
Baseline and Week 6.
|
|
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.
|
Baseline and Week 6.
|
|
Change in OCT / OCT-angiography parameters
Time Frame: Baseline and Week 6.
|
Change from baseline in GCC thickness (µm) measured by spectral-domain OCT.
|
Baseline and Week 6.
|
|
Change in OCT / OCT-angiography parameters
Time Frame: Baseline and Week 6.
|
Change from baseline in retinal vessel density (%) measured by OCT-angiography.
|
Baseline and Week 6.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in serum CRYAA concentration
Time Frame: One month.
|
Change from baseline in serum CRYAA concentration measured by ELISA (ng/mL).
|
One month.
|
|
Change in serum CRYAB concentration
Time Frame: one month
|
Change from baseline in serum CRYAB concentration measured by ELISA (ng/mL).
|
one month
|
|
Change in serum TRPV4 level
Time Frame: one month
|
Change from baseline in serum TRPV4 level measured by ELISA (ng/mL).
|
one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KB 672/2022, KB 258/2025
- SUBZ.A080.22.076 and Subz.A080 (Other Grant/Funding Number: Wroclaw Medical University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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