Effect of lutein and antioxidant dietary supplementation on contrast sensitivity in age-related macular disease: a randomized controlled trial. Methodology of the VECAT study: vitamin E intervention in cataract and age-related maculopathy. Oral zinc and the second eye in age-related macular degeneration. A randomized, prospective, placebo-controlled clinical trial of a novel zinc-monocysteine compound in age-related macular degeneration. 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). Carotenoids in Age-related Maculopathy Italian Study (CARMIS): two-year results of a randomized study. Visaline in the treatment of age-related macular degeneration: a pilot study. Oral zinc in macular degeneration.
The aim of the study is to determine the effect of lutein combined with vitamin and mineral supplementation on contrast sensitivity in people with age-related macular disease (ARMD).
                A prospective, 9-month, double-masked randomized controlled trial.
                Aston University, Birmingham, UK and a UK optometric clinical practice.
                Age-related maculopathy (ARM) and atrophic age-related macular degeneration (AMD) participants were randomized (using a random number generator) to either placebo (n=10) or active (n=15) groups. Three of the placebo group and two of the active group dropped out.
                The active group supplemented daily with 6 mg lutein combined with vitamins and minerals. The outcome measure was contrast sensitivity (CS) measured using the Pelli-Robson chart, for which the study had 80% power at the 5% significance level to detect a change of 0.3 log units.
                The CS score increased by 0.07+/-0.07 and decreased by 0.02+/-0.18 log units for the placebo and active groups, respectively. The difference between these values is not statistically significant (z=-0.903, P=0.376).
                The results suggest that 6 mg of lutein supplementation in combination with other antioxidants is not beneficial for this group. Further work is required to establish optimum dosage levels. Cataract is the leading cause of blindness in the world today, while age-related macular degeneration is responsible for the majority of new cases of visual impairment in the Western world. There is a growing body of evidence suggesting a role for antioxidant therapy to prevent the progression of these conditions. A 4-year prospective, randomised, controlled trial of an antioxidant versus placebo in a population of healthy volunteers aged 55-80 years at enrolment is described. This paper outlines the primary aims of the Vitamin E, Cataract and Age-related Macular Degeneration (VECAT) Study, the methodology, and the recruitment rates. Additional data on the toxicity and non-ocular effects of vitamin E will also be collected. Standardised clinical grading of macular and lens features, and comparison of serial macular photographs and digital lens photographs will form the basis for assessment of primary study outcomes. Information collected in this study will assist in the assessment of the potential value of antioxidants in preventing the enormous burden imposed on developed communities by age-related eye disease. In addition, important data on prevalence and progression rates of cataract and macular degeneration will be collected. To investigate the short-term effect of oral zinc substitution on the development of age-related macular degeneration in the second eye of patients with an exudative form of the disease in the first eye.
                A 2-year, double-masked, randomized, placebo-controlled study including 112 white patients with age-related macular degeneration and exudative lesions (choroidal neovascularization, pigment epithelial detachment, or both) in one eye and a visual acuity of better than 20/40 and macular degeneration without any exudative lesion in the second eye was performed. Patients received either 200 mg of oral zinc sulfate or placebo once daily for 24 months. The main outcome parameters were visual acuity, contrast sensitivity, color discrimination, and retinal grating acuity, as well as serum levels of zinc and copper, red blood cell count, hemoglobin, and morphologic changes detected by grading of monochrome fundus photographs and fluorescein angiograms.
                In the treatment group, the mean zinc serum level increased significantly (P < 0.0001) from 79 +/- 10 micrograms/dl to 108 +/- 26 micrograms/dl compared to no change (82 +/- 16 micrograms/dl to 85 +/- 10 micrograms/dl) in the placebo group. Serum levels of copper, hemoglobin, and red blood cell count did not change significantly in either group. A choroidal neovascular membrane (CNV) was detected in 14 patients during the treatment period (nine in the treatment group, five in the placebo group). Seven additional patients (three in the treatment group, four in the placebo group) experienced visual loss caused by CNV, and in two patients (one in each group), serous pigment epithelial detachment developed without angiographic evidence of CNV after the end of treatment, during a mean additional follow-up time of 20.8 +/- 8.2 months. In eyes in which exudative lesions did not develop, there was no significant change in any of the functional parameters during the 24-month treatment period, but there was a significant increase in the nonexudative alterations (drusen size, drusen confluence, hyperpigmentation, and focal degeneration of the retinal pigment epithelium) in both groups.
                Oral zinc substitution has no short-term effect on the course of age-related macular degeneration in patients who have an exudative form of the disease in one eye. To test the hypothesis that daily use of zinc-monocysteine (ZMC) supplement will be well tolerated and result in improved macular function in persons with dry age-related macular degeneration (AMD).
                Eligible, consenting subjects were randomized to either ZMC 25 mg or placebo twice daily for 6 months. Both ZMC and placebo groups enrolled 40 participants, with best corrected visual acuity 20/25 to 20/70, macular drusen, and pigment changes. Masked personnel determined baseline, 3- and 6-month best-corrected visual acuity, contrast sensitivity, and light flash recovery time. Differences between ZMC and placebo were analyzed by a one-sided unpaired t-test of the paired differences between baseline and 3- and 6-month timepoints for right and left eyes separately.
                By 6 months the ZMC group showed improved visual acuity (p < 0.0001) and contrast sensitivity (p < 0.0001). Macular light flash recovery time shortened in the ZMC group at 3 months by 2.1 sec (left eye, p = 0.0001) to 3.6 sec (right eye, p < 0.0001), and at 6 months by 7.2 sec (left eye, p < 0.0001) to 7.4 sec (right eye, p < 0.0001). This variable had no improvement in the placebo group. ZMC had a gastrointestinal irritation rate of under 2%.
                ZMC 25 mg twice daily was well tolerated and was associated with improved macular function in comparison to a placebo in persons with dry AMD. 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.
                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.
                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.
                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. The high concentration of carotenoids in the macula, plus evidence linking oxidative stress to age-related macular degeneration (AMD) and carotenoids to antioxidation, generated the hypothesis that higher antioxidant intakes can prevent AMD. The aim of this study was to determine whether nutritional supplementation with a targeted nutritional supplement improves visual acuity and visual function in AMD.
                In this multicenter, prospective open-label randomized study, 145 patients were randomly assigned to 2 different treatment groups. Interventions were lutein (10 mg), zeaxanthin (1 mg), astaxanthin (4 mg; AZYR SIFI, Catania, Italy), and antioxidants/vitamins supplementation formula or no dietary supplementation for 2 years. Primary outcome was mean changes in visual acuity (VA) at 12 and 24 months. Other measures included contrast sensitivity (CS) and National Eye Institute visual function questionnaire (NEI VFQ-25) scores at 12 and 24 months.
                Patients in the treated group showed stabilization of VA with significantly (p=0.003) better VA scores (81.4 ± 7.2) compared to the nontreated group (76.8 ± 8.9) at 24-month follow-up. An improvement in CS (p=0.001) and final mean NEI VFQ-25 composite scores at 12 and 24 months higher in treated group compared to nontreated group were also shown (p<0.001).
                Patients treated with lutein/zeaxanthin and astaxanthin together with other nutrients were more likely to report clinically meaningful stabilization/improvements in VA, CS, and visual function through 24 months compared with nontreated subjects. Further studies are needed with more patients and for longer periods of time. Age-related macular degeneration (AMD) is the main cause of a reduction in visual acuity in patients over the age of 65 years. A positive influence of medical treatment (i.e. with vitamins and trace minerals) has been suggested but remains unproven. In this randomized, double-blind study, 20 patients in an early stage of AMD were included. Over a period of 6 months, 9 patients were treated with Visaline and 11 with a placebo. The effect of the treatment was not statistically different between the two groups, admittedly small in number, in terms of visual and retinal acuity, color vision, and contrast sensitivity. Despite the lack of such measureable differences, the patients' own subjective assessments, however, were much better in the Visaline-treated group. Due to the short duration of the observation time, we can not comment on a possible long-term effect. Macular degeneration associated with age and drusen, an important cause of severe visual loss in older persons, is of unknown cause. The sensory retina and retinal pigment epithelium, which are cell layers in zinc, appear to be prominently involved in the disease process. Because zinc plays a role in the metabolic function of several important enzymes in the chorioretinal complex, we undertook a prospective, randomized, double-masked, placebo-controlled investigation of the effects of oral zinc administration on the visual acuity outcome in 151 subjects with drusen or macular degeneration. Although some eyes in the zinc-treated group lost vision, this group had significantly less visual loss than the placebo group after a follow-up of 12 to 24 months. This is the first controlled oral intervention study to show a positive, if limited, treatment effect in macular degeneration, a major public health problem. Because of the pilot nature of the study and the possible toxic effects and complications of oral zinc administration, widespread use of zinc in macular degeneration is not now warranted.