Presbyopia
Conditions
Keywords
Presbyopia, iridoids, anthocyanins, chokeberry, blueberry, honeysuckle berry
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.
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.
Interventions
DIETARY_SUPPLEMENTAKB
Standardized berry extract (Aronia melanocarpa, Lonicera caerulea, Vaccinium myrtillus), 400 mg capsule, BID, 6 weeks
OTHERPlacebo
Matching placebo capsules (maltodextrin + colouring), BID, 6 weeks
Sponsors
Wroclaw Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Intervention model description
randomised, double-blind, placebo-controlled, two-period crossover trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual field (automated perimetry) | 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) | 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) | 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) | 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) | 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 | Baseline and Week 6. | Change from baseline in RNFL thickness (µm) measured by spectral-domain OCT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum CRYAA concentration | One month. | Change from baseline in serum CRYAA concentration measured by ELISA (ng/mL). |
| Change in serum CRYAB concentration | one month | Change from baseline in serum CRYAB concentration measured by ELISA (ng/mL). |
| Change in serum TRPV4 level | one month | Change from baseline in serum TRPV4 level measured by ELISA (ng/mL). |
Countries
Poland
Outcome results
None listed