This randomized, double-blind, placebo-controlled study aims to evaluate the effect of krill oil supplementation in patients with dry age-related macular degeneration (AMD). Participants will receive 4 capsules of krill oil or placebo daily for a period of 3 months. Outcomes will be evaluated after 3-month treatment to assess differences between the two study groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Qualified subjects start to take supplementation from Day 1 in the trial. Specifically, subjects from Intervention group take 4 capsules of krill oil per day.
Qualified subjects start to take placebo from Day 1 in the trial. Specifically, subjects from placebo group take 4 capsules of olive oil, which has the same color and smell as the krill oil.
Shanghai General Hospital, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGChange in Macular Drusen Volume
Macular drusen volume will be quantified using spectral-domain optical coherence tomography (SD-OCT). Automated segmentation of Bruch's membrane and the retinal pigment epithelium (RPE), followed by manual verification, will be performed to calculate drusen volume at baseline and after 3 months of intervention at the same retinal location. Change in macular drusen volume will be defined as the percentage change from baseline, calculated as the difference between post-intervention and baseline drusen volume divided by the baseline drusen volume.
Time frame: From enrollment to the end of follow-up at 3 months.
Change in Maximum Macular Drusen Height
Maximum macular drusen height will be measured using SD-OCT at baseline and after 3 months of intervention. Change in maximum macular drusen height will be defined as the percentage change from baseline, calculated as the difference between post-intervention and baseline maximum drusen height divided by the baseline maximum drusen height.
Time frame: From enrollment to the end of follow-up at 3 months.
Change in Best-Corrected Visual Acuity
Best-corrected visual acuity (BCVA) will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and quantified as the total number of letters correctly identified by the participant. Change in BCVA will be defined as the absolute change in ETDRS letters from baseline, calculated as the difference between post-intervention and baseline measurements.
Time frame: From enrollment to the end of follow-up at 3 months.
Change in Self-Reported Visual Function
Self-reported visual function will be assessed using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Change in self-reported visual function will be defined as the absolute change in NEI VFQ-25 total score from baseline, calculated as the difference between post-intervention and baseline scores.
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Time frame: From enrollment to the end of follow-up at 3 months.