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| ID | Type | Description | Link |
|---|---|---|---|
| SUBZ.A080.22.076 and Subz.A080 | Other Grant/Funding Number | Wroclaw Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1: Dietary Supplement: AKB | Experimental | dose: 400 mg capsule, 1 capsule BID (2×/d) throug 6 weeks |
|
| Intervention 2: Placebo | Placebo Comparator | maltodextrin + natural caramel colouring, BID, 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKB | Dietary Supplement | Standardized berry extract (Aronia melanocarpa, Lonicera caerulea, Vaccinium myrtillus), 400 mg capsule, BID, 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum CRYAA concentration | Change from baseline in serum CRYAA concentration measured by ELISA (ng/mL). | One month. |
| Change in serum CRYAB concentration | Change from baseline in serum CRYAB concentration measured by ELISA (ng/mL). |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wroclaw Medical University | Wroclaw | 50-367 | Poland |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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randomised, double-blind, placebo-controlled, two-period crossover trial
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Double (Participant, Investigator)
| Placebo | Other | Matching placebo capsules (maltodextrin + colouring), BID, 6 weeks |
|
| 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. |
| one month |
| Change in serum TRPV4 level | Change from baseline in serum TRPV4 level measured by ELISA (ng/mL). | one month |