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James Loughman, Colm J O'Brien, John S Butler, Ian Flitcroft, Ekaterina Loskutova; Macular pigment response to carotenoid supplementation in patients with open angle glaucoma: the ENIGMA trial.. Invest. Ophthalmol. Vis. Sci. 2021;62(8):2953.
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© ARVO (1962-2015); The Authors (2016-present)
Recent investigations have demonstrated that macular pigment (MP is lower in glaucomatous eyes. MP exhibits specific biological qualities which may confer neuro-protective and functional benefits in glaucoma. The European Nutrition In Glaucoma Management (ENIGMA) trial was designed to evaluate, for the first time, the MP response to supplementation in glaucoma.
ENIGMA (NCT04460365) comprised a randomized, placebo controlled, double masked trial. Individuals with open angle glaucoma, VA < 0.3, no other ocular disease, and no history of dementia were eligible for inclusion. Participants were randomized in a 2:1 ratio to receive a dietary carotenoid supplement [10mg lutein (L), 10mg meso-zeaxanthin (meso-Z) and 2mg zeaxanthin (Z)], or placebo for 18 months. MPOD was measured at baseline, 6, 12 and 18 months by dual-wavelength autofluorescence using Heidelberg Spectralis.
62 participants were enrolled, 44 assigned to treatment and 18 to placebo. No baseline differences between groups were observed (P > 0.05 for all -Table 1). Repeated measures ANOVA showed that sqrt MPOD volume differed significantly for the interaction between treatment and time [F(3,111)= 31.718690, p < 0.001] with a significant effect of time [F(3,111)= 71.277135, p < 0.001] and no significant effect of treatment [F(1,37)= 2.642403, p =0.112]. Post hoc tests with Bonferroni correction revealed a significant difference between baseline MPOD and MPOD at each timepoint (6, 12 and 18 months) in the treatment group only (Fig 1). There was a significant difference in MPOD volume between the treatment and placebo group at 12 and 18 months.
ENIGMA is the first study to demonstrate that MP levels can be augmented in glaucomatous eyes by carotenoid supplementation, which represents an important pre-cursor to any functional or health-related benefits that may accrue. From a neuro-protective perspective, oxidative stress and chronic inflammation are key pathways of tissue damage involved in glaucoma. As potent antioxidant and anti-inflammatory nutrients, L, Z and meso-Z supplementation to increase MPOD might support retinal ganglion cells and confer protection by preventing the pathophysiological cascades of oxidative stress and inflammation in glaucoma.
This is a 2021 ARVO Annual Meeting abstract.
Table 1: Participant demographics, baseline and 18-month follow up data
Fig 1: Change in MPOD Volume from baseline in treatment and placebo groups.
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