Randomized, three-group, parallel comparative study on changes in macular pigment optical density and visual function due to administration of supplements containing lutein and omega3 fatty acids to patients with age-related macular degeneration (patients treated with ranibizumab)
- Conditions
- age-related macular degeneration
- Registration Number
- JPRN-UMIN000004804
- Lead Sponsor
- Seirei Hamamatsu Genaral Hospital (Shizuoka Prefecture)
- Brief Summary
The mean macular pigment optical density levels increased at month 12 compared to the baseline in all groups, but a statistically significant increase was observed only in group MMLD (multivitamins and minerals plus 12 mg lutein, p=0.023, Wilcoxon signed rank test). The mean frequency of retreatment was 2.6 in group MM ( multivitamins and minerals), 3.3 in group MML, and 1.6 in MMLD (multivitamins and minerals, plus lutein and 144 mg docosahexaenoic acid, p=0.338, Kruskal-Wallis test).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 28
Not provided
(1) Presence of cataracts of a severity sufficient to materially affect the above evaluations of visual function (2)Undergone cataract surgery within the previous 3 months (3)Pupile size of less than 6.5 mm (4)Presence of glaucoma, diabetic retinopathy, or other serious disease of the fundus (5)Myopia of -6D or higher (6)Presence of hepatopathy, nephropathy, or cardiac disease of a severity sufficient to affect the evaluations of the supplements to be taken by patients (7)Receiving photosensitive drugs such as phenothiazine, chloroquine, and tetracycline on an ongoing basis (8)Regular use of lutein or DHA in the past 3 months (9)Judged by the investigator to be ineligible for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method