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Mitochondrial DNA A3243G variant-associated retinopathy: a meta-analysis of the clinical course of visual acuity and correlation with systemic manifestations.
Coussa, RG, Sohn, EH, Han, IC, Parikh, S, Traboulsi, EI
Ophthalmic genetics. 2021;(4):420-430
Abstract
PURPOSE The mitochondrial DNA A3243G (m.3243A>G) variant causes a wide spectrum of phenotypes, with pigmentary retinopathy as the most common ocular finding. We undertook this meta-analysis to investigate the clinical course of visual acuity (VA) in patients with m.3243A>G variant and provide key clinical correlations with systemic manifestations. METHODS A PubMed literature search was performed and studies were selected after satisfying pre-set inclusion criteria. Demographic and clinical data, including retinal findings and systemic manifestations were recorded. Cross-sectional and linear regression analyses were used to investigate the relationship between VA and age, as well as between the age at diagnosis of retinopathy and the mean ages at diagnosis of sensorineural hearing loss or diabetes. The age and prevalence of systemic manifestations among patients with and without retinopathy were studied using t-tests and Mann-Whitney U-tests (performed on binarized data). Likelihood ratios were computed. RESULTS The mean VA (average of both eyes) of 90 patients (72.2% female; 65/90) were collected from 18 studies published between 1990 and 2018. The baseline mean age was 45.2 years (range 17 to 92). The mean logMAR VA was 0.10 (- 0.12 to 1.39). There was a statistically significant linear correlation between the logMAR VA and age (p = .008). The VA of patients less than or equal to 50 years of age was significantly better than that of patients older than 50 years (0.06 vs.0.18 logMAR, p = .002). 67 patients (74.4%) showed a characteristic pigmentary retinopathy with a mean age at diagnosis of 47.9 years (17 to 92) and VA of 0.14 logMAR (- 0.12 to 1.24). Age at diagnosis of retinopathy was linearly correlated with age at diagnosis of hearing loss or diabetes (p < .001). Patients with retinopathy were more likely to have hearing loss (83.6% vs. 56.5%, p = .03) or diabetes (56.7% vs. 17.4%, p = .001) than those without retinopathy. Those with both hearing loss and diabetes had an earlier onset of retinopathy than those without (46.4 vs. 60.4 years, p = .01). Patients without both hearing loss and diabetes were 5.3-fold less likely to develop a retinopathy. CONCLUSIONS Patients with m.3243A>G variant pigmentary retinopathy maintain highly functional VA until around the fifth decade of life, after which significant visual decline ensues. Patients without hearing loss and diabetes have a lower likelihood of exhibiting a retinopathy, which tends to appear about one decade after hearing loss and diabetes are diagnosed.
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Efficacy and Treatment Burden of Intravitreal Aflibercept Versus Intravitreal Ranibizumab Treat-and-Extend Regimens at 2 Years: Network Meta-Analysis Incorporating Individual Patient Data Meta-Regression and Matching-Adjusted Indirect Comparison.
Ohji, M, Lanzetta, P, Korobelnik, JF, Wojciechowski, P, Taieb, V, Deschaseaux, C, Janer, D, Tuckmantel, C
Advances in therapy. 2020;(5):2184-2198
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PURPOSE To compare visual outcomes and treatment burden between intravitreally administered aflibercept (IVT-AFL) and ranibizumab (RBZ) treat-and-extend (T&E) regimens in patients with wet age-related macular degeneration (wAMD) at 2 years. METHODS A systematic literature review was carried out in Medline, EMBASE, and CENTRAL in October 2018. Matching-adjusted indirect comparison (MAIC) and/or individual patient data meta-regression was used to connect ALTAIR (assessing IVT-AFL T&E) with other studies, adjusting for between-trial differences in baseline visual acuity and age or baseline visual acuity, age, and polypoidal choroidal vasculopathy (PCV) status. Sensitivity analyses were conducted to test the robustness of the results, including direct MAIC between IVT-AFL T&E (ALTAIR) and RBZ T&E (CANTREAT and TREX-AMD trials). RESULTS Six randomized controlled trials (RCTs) (ALTAIR, VIEW 1 and 2, CATT, CANTREAT, and TREX) were included in the analysis. IVT-AFL T&E was assessed in one study, ALTAIR (n = 255), while RBZ T&E was assessed in two trials (n = 327). At 2 years, the median difference (95% credibility interval) between IVT-AFL T&E and RBZ T&E regarding the numbers of Early Treatment Diabetic Retinopathy Study (ETDRS) letters gained was not significant (M1: - 2.29 [- 8.10, 3.58]; M2: - 0.55 [- 6.34, 5.29]). IVT-AFL T&E was associated with significantly fewer injections than RBZ-T&E (M1: - 6.12 [- 7.60, - 4.65]; M2: - 5.93 [- 7.42, - 4.45]). Results of the sensitivity analyses were consistent with the main scenarios. CONCLUSION Patients with wAMD receiving an IVT-AFL T&E regimen achieved and maintained improvement in visual acuity with fewer injections over 2 years compared with RBZ T&E. IVT-AFL T&E may therefore serve as the optimal therapy for wAMD, as it was associated with clinical efficacy and minimized treatment burden.
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n-3 Fatty Acid Supplementation in Mothers, Preterm Infants, and Term Infants and Childhood Psychomotor and Visual Development: A Systematic Review and Meta-Analysis.
Shulkin, M, Pimpin, L, Bellinger, D, Kranz, S, Fawzi, W, Duggan, C, Mozaffarian, D
The Journal of nutrition. 2018;(3):409-418
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BACKGROUND Epidemiologic studies link maternal seafood and n-3 (ω-3) polyunsaturated fatty acid (PUFA) consumption with improved childhood cognitive development; trials show mixed results. OBJECTIVE We investigated effects of n-3 PUFA supplementation on child cognitive and visual outcomes. METHODS We systematically reviewed and meta-analyzed randomized controlled trials of n-3 PUFA supplementation in mothers or infants (age ≤2 y) and evaluated standardized measures of cognitive or visual development up to age 18 y. Of 6286 abstracts and 669 full-text articles, 38 trials with 53 intervention arms were included. Data were extracted independently in duplicate. Findings were pooled using random-effects meta-analysis across supplementation periods (maternal, preterm, term infant); we also explored subgroup analyses stratified by supplementation period. Heterogeneity was explored using I2, stratified analysis, and meta-regression. Cognitive development was assessed by Bayley Scales of Infant Development mental and psychomotor developmental indexes (MDI, PDI) and intelligence quotient (IQ); visual acuity was assessed by electrophysiological or behavioral measures. RESULTS The 38 trials (mothers: n = 13; preterm infants: n = 7; term infants: n = 18) included 5541 participants. When we explored effects during different periods of supplementation, n-3 PUFA supplementation improved MDI in preterm infants (3.33; 95% CI: 0.72, 5.93), without statistically significant effects on PDI or IQ in different intervention period subgroups. Visual acuity [measured as the logarithm of the minimum angle of resolution (logMAR)] was improved by supplementation in preterm (-0.08 logMAR; 95% CI: -0.14, -0.01 logMAR) and term infants (-0.08 logMAR; 95% CI: -0.11, -0.05 logMAR), with a nonsignificant trend for maternal supplementation (-0.02 logMAR; 95% CI: -0.04, 0.00 logMAR). In main analyses pooling all supplementation periods, compared with placebo, n-3 PUFA supplementation improved MDI (n = 21 trials; 0.91; 95% CI: 0.005, 1.81; P = 0.049), PDI (n = 21 trials; 1.06 higher index; 95% CI: 0.10, 2.03; P = 0.031), and visual acuity (n = 24; -0.063 logMAR; 95% CI: -0.084, -0.041 logMAR; P < 0.001) but not IQ (n = 7; 0.20; 95% CI: -1.56, 1.96, P = 0.83), although few studies assessed this endpoint. Potential publication bias was identified for MDI (Eggers P = 0.005), but not other endpoints. Significant differences in findings were not identified by world region, race, maternal education, age at outcome assessment, supplementation duration, DHA or EPA dose, DHA:AA ratio, or study quality score (P-interaction > 0.05 each). CONCLUSIONS n-3 PUFA supplementation improves childhood psychomotor and visual development, without significant effects on global IQ later in childhood, although the latter conclusion is based on fewer studies.
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Longchain polyunsaturated fatty acid supplementation in preterm infants.
Moon, K, Rao, SC, Schulzke, SM, Patole, SK, Simmer, K
The Cochrane database of systematic reviews. 2016;(12):CD000375
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BACKGROUND Controversy exists over whether longchain polyunsaturated fatty acids (LCPUFA) are essential nutrients for preterm infants because they may not be able to synthesise sufficient amounts of LCPUFA to meet the needs of the developing brain and retina. OBJECTIVES To assess whether supplementation of formula milk with LCPUFA is safe and of benefit to preterm infants. The main areas of interest were the effects of supplementation on the visual function, development and growth of preterm infants. SEARCH METHODS Trials were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2) in the Cochrane Library (searched 28 February 2016), MEDLINE Ovid (1966 to 28 February 2016), Embase Ovid (1980 to 28 February 2016), CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1980 to 28 February 2016), MEDLINE In Process & Other Non-indexed Citations (1966 to 28 February 2016) and by checking reference lists of articles and conference proceedings. We also searched ClinicalTrials.gov (13 April 2016). No language restrictions were applied. SELECTION CRITERIA All randomised trials evaluating the effect of LCPUFA-supplemented formula in enterally-fed preterm infants (compared with standard formula) on visual development, neurodevelopment and physical growth. Trials reporting only biochemical outcomes were not included. DATA COLLECTION AND ANALYSIS All authors assessed eligibility and trial quality, two authors extracted data separately. Study authors were contacted for additional information. MAIN RESULTS Seventeen trials involving 2260 preterm infants were included in the review. The risk of bias varied across the included trials with 10 studies having low risk of bias in a majority of the domains. The median gestational age (GA) in the included trials was 30 weeks and median birth weight (BW) was 1300 g. The median concentration of docosahexaenoic acid (DHA) was 0.33% (range: 0.15% to 1%) and arachidonic acid (AA) 0.37% (range: 0.02% to 0.84%). Visual acuity Visual acuity over the first year was measured by Teller or Lea acuity cards in eight studies, by visual evoked potential (VEP) in six studies and by electroretinogram (ERG) in two studies. Most studies found no significant differences in visual acuity between supplemented and control infants. The form of data presentation and the varying assessment methods precluded the use of meta-analysis. A GRADE analysis for this outcome indicated that the overall quality of evidence was low. Neurodevelopment Three out of seven studies reported some benefit of LCPUFA on neurodevelopment at different postnatal ages. Meta-analysis of four studies evaluating Bayley Scales of Infant Development at 12 months (N = 364) showed no significant effect of supplementation (Mental Development Index (MDI): MD 0.96, 95% CI -1.42 to 3.34; P = 0.43; I² = 71% - Psychomotor DeveIopment Index (PDI): MD 0.23, 95% CI -2.77 to 3.22; P = 0.88; I² = 81%). Furthermore, three studies at 18 months (N = 494) also revealed no significant effect of LCPUFA on neurodevelopment (MDI: MD 2.40, 95% CI -0.33 to 5.12; P = 0.08; I² = 0% - PDI: MD 0.74, 95% CI -1.90 to 3.37; P = 0.58; I² = 54%). A GRADE analysis for these outcomes indicated that the overall quality of evidence was low. Physical growth Four out of 15 studies reported benefits of LCPUFA on growth of supplemented infants at different postmenstrual ages (PMAs), whereas two trials suggested that LCPUFA-supplemented infants grow less well. One trial reported mild reductions in length and weight z scores at 18 months. Meta-analysis of five studies (N = 297) showed increased weight and length at two months post-term in supplemented infants (Weight: MD 0.21, 95% CI 0.08 to 0.33; P = 0.0010; I² = 69% - Length: MD 0.47, 95% CI 0.00 to 0.94; P = 0.05; I² = 0%). Meta-analysis of four studies at a corrected age of 12 months (N = 271) showed no significant effect of supplementation on growth outcomes (Weight: MD -0.10, 95% CI -0.31 to 0.12; P = 0.34; I² = 65% - Length: MD 0.25; 95% CI -0.33 to 0.84; P = 0.40; I² = 71% - Head circumference: MD -0.15, 95% CI -0.53 to 0.23; P = 0.45; I² = 0%). No significant effect of LCPUFA on weight, length or head circumference was observed on meta-analysis of two studies (n = 396 infants) at 18 months (Weight: MD -0.14, 95% CI -0.39 to 0.10; P = 0.26; I² = 66% - Length: MD -0.28, 95% CI -0.91 to 0.35; P = 0.38; I² = 90% - Head circumference: MD -0.18, 95% CI -0.53 to 0.18; P = 0.32; I² = 0%). A GRADE analysis for this outcome indicated that the overall quality of evidence was low. AUTHORS' CONCLUSIONS Infants enrolled in the trials were relatively mature and healthy preterm infants. Assessment schedule and methodology, dose and source of supplementation and fatty acid composition of the control formula varied between trials. On pooling of results, no clear long-term benefits or harms were demonstrated for preterm infants receiving LCPUFA-supplemented formula.
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Ranibizumab treatment outcomes in phakic versus pseudophakic eyes: an individual patient data analysis of 2 phase 3 trials.
Weinberg, DV, Shapiro, H, Ehrlich, JS
Ophthalmology. 2013;(6):1278-82
Abstract
OBJECTIVE To compare visual outcomes in phakic and pseudophakic eyes treated with monthly intravitreal ranibizumab for exudative age-related macular degeneration (AMD). DESIGN Meta-analysis of individual patient data from 2 phase 3 clinical trials of intravitreal ranibizumab in neovascular AMD (Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration [ANCHOR], ClinicalTrials.gov number, NCT00061594; and Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration [MARINA], ClinicalTrials.gov number NCT00056836). PARTICIPANTS AND CONTROLS A total of 1137 patients from 2 phase 3 clinical trials. METHODS Phakic and pseudophakic eyes were treated with monthly intravitreal ranibizumab (0.3 mg or 0.5 mg), sham injections plus verteporfin photodynamic therapy (ANCHOR), or sham injections alone (MARINA). MAIN OUTCOME MEASURES Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) and the proportion of patients gaining or losing 15 or more ETDRS letters. RESULTS After adjusting for baseline covariates, no differences were seen in mean change in VA for phakic versus pseudophakic eyes. Pseudophakic eyes were more likely to lose 15 or more letters of vision than phakic eyes at 12 months, but not at 24 months. CONCLUSIONS Overall, in this analysis, lens status did not demonstrate an independent influence on mean VA for eyes treated with monthly ranibizumab. It is possible that phakic eyes may be less prone to severe vision loss. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
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Visual acuity after intravitreal triamcinolone for diabetic macular edema refractory to laser treatment: a meta-analysis.
Rudnisky, CJ, Lavergne, V, Katz, D
Canadian journal of ophthalmology. Journal canadien d'ophtalmologie. 2009;(5):587-93
Abstract
OBJECTIVE To quantify the effect on visual acuity of intravitreal triamcinolone for the treatment of laser-refractory diabetic macular edema (DME). STUDY DESIGN Meta-analysis of eligible studies identified by searching MEDLINE, EMBASE, the Cochrane Library, and Google. PARTICIPANTS 7 randomized controlled trials and 3 cohort studies. METHODS A search of the literature between 1950 and September 2008 identified 540 articles. Studies that evaluated the efficacy of triamcinolone for the treatment of DME refractory to laser photocoagulation, reported visual acuity data, and compared the intervention with an appropriate control group were included. Exclusion criteria were studies of non-DME, triamcinolone used as an adjunct to another treatment, and triamcinolone delivery other than intravitreally. RESULTS Using a random-effects model, there was a statistically significant summary mean difference in visual acuity of -0.313 logarithm of the minimum angle of resolution (logMAR) units (95% CI -0.551, -0.074) after 1 month of follow-up. This difference declined to -0.125 logMAR units (95% CI -0.181, -0.070) by 3 months and to -0.043 logMAR units (95% CI -0.090, 0.003) by 6 months. No evidence of publication bias was present. There was a high level of heterogeneity in this group of studies (meta-analysis of 1-month follow-up data: Q-statistic = 21.987, p< 0.001), attributable primarily to study design. CONCLUSIONS These meta-analyses demonstrate that intravitreal triamcinolone results in a temporary improvement of visual acuity in patients with laser-refractory DME, with a peak benefit of approximately 3 lines of visual acuity 1 month postinjection.
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Duration of long-chain polyunsaturated fatty acids availability in the diet and visual acuity.
Morale, SE, Hoffman, DR, Castañeda, YS, Wheaton, DH, Burns, RA, Birch, EE
Early human development. 2005;(2):197-203
Abstract
BACKGROUND Little is known about the critical period during which the dietary supply of long-chain polyunsaturated fatty acids (LCPUFAs) may influence the maturation of visual cortical function in term infants. AIM: To define the relationship between duration of dietary LCPUFA supply and visual acuity at 52 weeks of age. STUDY DESIGN Data from 243 infants who participated in four randomized clinical trials of LCPUFA supplementation of infant formula at a single research center were combined. The primary outcome was visual acuity at 52 weeks of age as measured by swept visual evoked potentials (sweep VEP). RESULTS Longer duration of LCPUFA supply was associated with better mean acuity at 52 weeks of age (r=-0.878; p<0.001). The relationship between duration of dietary LCPUFA supply and sweep VEP acuity at 52 weeks was similar whether the LCPUFAs were provided via formula containing 0.36% DHA and 0.72% ARA or human milk. Duration of breast-feeding was associated with individual infants' sweep VEP acuity outcomes at 52 weeks (r=-0.286; p<0.005). The duration of LCPUFA supply during infancy has a similar relationship to sweep VEP acuity at 52 weeks in breastfed infants regardless of birth order. CONCLUSION A continued benefit from a supply of LCPUFAs is apparent in infants through 52 weeks of age, suggesting that the brain may not have sufficient stores of LCPUFAs from an early postnatal supply to support the optimal maturation of the visual cortex.