Diabetic Retinopathy - Treatment

Lutein - updated: 09 April 2008

Double-masked, placebo-controlled, randomized trial of lutein and antioxidant supplementation in the intervention of atrophic age-related macular degeneration: the Veterans LAST study (Lutein Antioxidant Supplementation Trial).

Optometry. 2004 Apr;75(4):216-30

Richer S, Stiles W, Statkute L, Pulido J, Frankowski J, Rudy D, Pei K, Tsipursky M, Nyland J.

BACKGROUND: Age-related macular degeneration (ARMD) is the leading cause of vision loss in aging Westem societies. The objective of the lutein antioxidant supplementation trial (LAST) is to determine whether nutritional supplementation with lutein or lutein together with antioxidants, vitamins, and minerals, improves visual function and symptoms in atrophic ARMD. METHODS: The study was a prospective, 12-month, randomized, double-masked, placebo-controlled trial conducted at an urban midwestern Veterans Administration Hospital from August 1999 to May 2001. Ninety patients with atrophic ARMD were referred by ophthalmologists at two Chicago-area veterans medical facilities. Patients in Group 1 received lutein 10 mg (L); in Group 2, a lutein 10 mg/antioxidants/vitamins and minerals broad spectrum supplementation formula (L/A); and in Group 3, a maltodextrin placebo (P) over 12 months. RESULTS: In Groups 1 L and 2 L/A, mean eye macular pigment optical density increased approximately 0.09 log units from baseline, Snellen equivalent visual acuity improved 5.4 letters for Group 1 L and 3.5 letters for Group 2 L/A, and contrast sensitivity improved. There was a net subjective improvement in Amsler grid in Group 1 L. VFO-14 questionnaires conceming subjective glare recovery were nearly significant at 4 months for Group 2 L/A. Patients who received the placebo (Group 3) had no significant changes in any of the measured findings. CONCLUSION: In this study, visual function is improved with lutein alone or lutein together with other nutrients. Further studies are needed with more patients, of both genders, and for longer periods of time to assess long-term effects of lutein or lutein together with a broad spectrum of antioxidants, vitamins, and minerals in the treatment of atrophic age-related macular degeneration.

Publication Types:

• randomized, double-masked, placebo-controlled trial

Lutein supplementation in retinitis pigmentosa: PC-based vision assessment in a randomized double-masked placebo-controlled clinical trial [NCT00029289].

BMC Ophthalmol. 2006 Jun 7;6:23

Bahrami H, Melia M, Dagnelie G.

BACKGROUND: There is no generally accepted medical or surgical treatment to stop the progressive course of retinitis pigmentosa. Previous studies have suggested lutein as a potential treatment with positive effects on macular pigment density. The objective of this study was to examine the effect of lutein supplementation on preservation of visual function in patients with retinitis pigmentosa (RP) METHODS: In a double-masked randomized placebo-controlled phase I/II clinical trial with a cross-over design, 34 adult patients with RP were randomized to two groups. One group, consisted of 16 participants, received lutein supplementation (10 mg/d for 12 wks followed by 30 mg/d) for the first 24 weeks and then placebo for the following 24 weeks, while the other group included 18 participants for whom placebo (24 weeks) was administered prior to lutein. Visual acuity, contrast sensitivity, and central visual field were measured at different illumination levels at baseline and every week using a PC-based test at home. RESULTS: For visual acuity (VA) at normal illumination level, treatment with lutein reduced logMAR, i.e. improved VA, but this effect was not statistically significant. The changes in normal (100%), low (4%), and very low (0.1%) illumination log CS were not statistically significant (p-values: 0.34, 0.23, and 0.32, respectively). Lutein had a statistically significant effect on visual field (p-value: 0.038) and this effect increased in the model assuming a 6-week delay in effect of lutein. Comparing the development of vision measures against the natural loss expected to occur over the course of 48 weeks, most measures showed reduced decline, and these reductions were significant for normal illumination VA and CS. CONCLUSION: These results suggest that lutein supplementation improves visual field and also might improve visual acuity slightly, although these results should be interpreted cautiously. As a combined phase I and II clinical trial, this study demonstrated the efficacy and safety of lutein supplementation.

Publication Types:

• double-masked randomized placebo-controlled phase I/II clinical trial with a cross-over design

Lutein and beta-carotene from lutein-containing yellow carrots are bioavailable in humans

Am J Clin Nutr. 2004 Jul;80(1):131-6.

Molldrem KL, Li J, Simon PW, Tanumihardjo SA.

BACKGROUND: Lutein is a hydroxy-carotenoid constituting the macular pigment of the human retina. Increasing lutein intake from foods could increase the density of this pigment and decrease the risk of developing macular degeneration. Yellow carrots are a novel food source that could increase lutein consumption. OBJECTIVE: We evaluated and compared lutein uptake and clearance in humans from genetically selected lutein-containing yellow carrots fed chronically and from a lutein supplement. DESIGN: Four women and 5 men aged 23-28 y participated in this randomized, blinded, 3 x 3 crossover intervention. Treatments consisted of yellow carrots (YC treatment, 1.7 mg lutein/d), white carrots as a negative control (WC treatment, 0 mg lutein/d), and a lutein supplement in oil as a positive control (LS treatment, 1.7 mg lutein/d). Each treatment lasted 7 d and was followed by a 7-d washout period. RESULTS: Mean (+/- SD) peak changes in serum lutein concentration from baseline were 0.31 +/- 0.08, 0.19 +/- 0.08, and -0.04 +/- 0.04 micromol/L for the LS, YC, and WC treatments, respectively. The areas under the curve for 0-14 d (AUC(0-14d)) differed significantly (P < 0.0001) between treatments. Lutein from the YC treatment was 65% as bioavailable as that from the LS treatment. The AUC(0-14d) for beta-carotene (-0.01 +/- 0.28 micromol.d/L) also showed that the YC treatment maintained peak serum beta-carotene concentrations at 0.35 +/- 0.30 micromol/L, whereas the LS treatment did not (AUC(0-14d) = -0.71 +/- 0.59 micromol.d/L). CONCLUSION: Lutein from this novel food source significantly increases serum lutein concentrations and does not result in the decrease in beta-carotene concentrations that accompanies administration of lutein supplements.

Publication Types:

• randomized, blinded, 3 x 3 crossover intervention

Dose-ranging study of lutein supplementation in persons aged 60 years or older

Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5227-33

Rosenthal JM, Kim J, de Monasterio F, Thompson DJ, Bone RA, Landrum JT, de Moura FF, Khachik F, Chen H, Schleicher RL, Ferris FL 3rd, Chew EY.

PURPOSE: To examine the dose-response relationship between oral lutein supplementation and serum lutein concentrations in persons aged 60 years and older, with or without age-related macular degeneration (AMD). METHODS: Forty-five participants with no AMD, large drusen, or advanced AMD, were randomized to receive one of three doses (2.5, 5, or 10 mg) of lutein for 6 months and to be observed for 6 additional months after the cessation of lutein supplementation. RESULTS: The mean age of the participants (33 women) was 71 years (range: 60-91). The serum lutein concentrations of each dose group were similar before supplementation, increased at 1 month, and peaked by 3 months. Median serum concentrations of the 2.5-, 5-, and 10-mg groups from baseline to month 6 increased from 18.7 to 35.1 microg/dL (2-fold increase), from 17.8 to 59.2 microg/dL (2.9-fold increase), and from 15.1 to 66.8 microg/dL (4-fold increase), respectively (all P < 0.001). The increases in lutein serum concentrations did not vary with AMD disease severity (P = 0.98). No toxicity was observed with any dose of lutein. No significant changes were detected in visual acuity or visual field tests. CONCLUSIONS: Increasing doses of lutein supplements significantly increased the serum levels of lutein and zeaxanthin, and doses up to 10 mg were safely administered. A long-term large clinical trial is necessary to investigate the safety and efficacy of lutein in reducing the risk of the development of advanced AMD.

Publication Types:

• randomized to receive one of three doses (2.5, 5, or 10 mg) of lutein

Publication Types:

• Review