Customizing Clinical Outcomes with Implantation of Two Diffractive Trifocal IOLs of Identical Design but Differing Light Distributions to the Far, Intermediate and Near Foci

Hakan Kaymak,1,2 Richard Potvin,3 Kai Neller,1,2 Karsten Klabe,1 Robert Donald Anello4 On behalf of the NINO Study Group1Internationale Innovative Ophthalmochirurgie GbR, Duesseldorf, Germany; 2Institute of Experimental Ophthalmology, Saarland University, Homburg/Saar, Germany; 3Science in Vision, Frisco, TX, USA; 4Global Clinical and Medical Affairs, Hoya Surgical Optics, Irvine, CA, USACorrespondence: Robert Donald Anello, HOYA Surgical Optics, 110 Progress, Suite 175, Irvine, CA, 92618, USA, Tel +1 909-224-6149, Email [email protected]: To evaluate clinical outcomes after bilateral or contralateral implantation of the Gemetric™ (G) and Gemetric™ Plus (GPlus) diffractive trifocal intraocular lenses (IOLs).Methods: This was a prospective, randomized, multi-center open-label study comparing clinical results and subjective patient responses around 6 months after implantation of the study lenses (toric and non-toric) in three different groups (bilateral G, bilateral GPlus and contralateral G/GPlus implantation). Results included the manifest refraction, uncorrected and distance corrected monocular and binocular visual acuity (VA) at distance, intermediate and near; the defocus curve; contrast sensitivity; and patient reported outcomes regarding spectacle independence, satisfaction and visual disturbances.Results: There was no statistically significant difference in the mean refraction spherical equivalent between the two lens models (p = 0.33) or between the toric and non-toric lenses (p = 0.06). Monocular VA was better at distance with the G lens and better at near with the GPlus lens (p 0.24).Conclusion: The two diffractive trifocal IOLs studied here may be used either bilaterally or contralaterally for the correction of presbyopia in cataract patients, providing excellent visual acuity with low levels of visual disturbances and high rates of overall spectacle independence. Bilateral Gemetric implantation resulted in slightly better distance and intermediate vision while contralateral implantation provided slightly better near vision. There was no apparent advantage to implanting the GPlus IOL bilaterally.Keywords: Gemetric™, Gemetric™ Plus, trifocal, presbyopia-correcting, diffractive, trifocal, Vivinex&#x212

Autism and Intellectual Disability Are Differentially Related to Sociodemographic Background at Birth

Background: Research findings investigating the sociodemographics of autism spectrum disorder (ASD) have been inconsistent and rarely considered the presence of intellectual disability (ID). Methods: We used population data on Western Australian singletons born from 1984 to 1999 (n = 398,353) to examine the sociodemographic characteristics of children diagnosed with ASD with or without ID, or ID without ASD compared with non-affected children. Results: The profiles for the four categories examined, mild-moderate ID, severe ID, ASD without ID and ASD with ID varied considerably and we often identified a gradient effect where the risk factors for mild-moderate ID and ASD without ID were at opposite extremes while those for ASD with ID were intermediary. This was demonstrated clearly with increased odds of ASD without ID amongst older mothers aged 35 years and over (odds ratio (OR) = 1.69 [CI: 1.18, 2.43]), first born infants (OR = 2.78; [CI: 1.67, 4.54]), male infants (OR = 6.57 [CI: 4.87, 8.87]) and increasing socioeconomic advantage. In contrast, mild-moderate ID was associated with younger mothers aged less than 20 years (OR = 1.88 [CI: 1.57, 2.25]), paternal age greater than 40 years (OR = 1.59 [CI: 1.36, 1.86]), Australian-born and Aboriginal mothers (OR = 1.60 [CI: 1.41, 1.82]), increasing birth order and increasing social disadvantage (OR = 2.56 [CI: 2.27, 2.97]). Mothers of infants residing in regional or remote areas had consistently lower risk of ASD or ID and may be linked to reduced access to services or underascertainment rather than a protective effect of location. Conclusions: The different risk profiles observed between groups may be related to aetiological differences or ascertainment factors or both. Untangling these pathways is challenging but an urgent public health priority in view of the supposed autism epidemic

Advanced paternal age effects in neurodevelopmental disorders?review of potential underlying mechanisms

Multiple epidemiological studies suggest a relationship between advanced paternal age (APA) at conception and adverse neurodevelopmental outcomes in offspring, particularly with regard to increased risk for autism and schizophrenia. Conclusive evidence about how age-related changes in paternal gametes, or age-independent behavioral traits affect neural development is still lacking. Recent evidence suggests that the origins of APA effects are likely to be multidimensional, involving both inherited predisposition and de novo events. Here we provide a review of the epidemiological and molecular findings to date. Focusing on the latter, we present the evidence for genetic and epigenetic mechanisms underpinning the association between late fatherhood and disorder in offspring. We also discuss the limitations of the APA literature. We propose that different hypotheses relating to the origins of the APA effects are not mutually exclusive. Instead, multiple mechanisms likely contribute, reflecting the etiological complexity of neurodevelopmental disorders

Investigating clinical heterogeneity in systematic reviews: a methodologic review of guidance in the literature

<p>Abstract</p> <p>Background</p> <p>While there is some consensus on methods for investigating statistical and methodological heterogeneity, little attention has been paid to clinical aspects of heterogeneity. The objective of this study is to summarize and collate suggested methods for investigating clinical heterogeneity in systematic reviews.</p> <p>Methods</p> <p>We searched databases (Medline, EMBASE, CINAHL, Cochrane Library, and CONSORT, to December 2010) and reference lists and contacted experts to identify resources providing suggestions for investigating clinical heterogeneity between controlled clinical trials included in systematic reviews. We extracted recommendations, assessed resources for risk of bias, and collated the recommendations.</p> <p>Results</p> <p>One hundred and one resources were collected, including narrative reviews, methodological reviews, statistical methods papers, and textbooks. These resources generally had a low risk of bias, but there was minimal consensus among them. Resources suggested that planned investigations of clinical heterogeneity should be made explicit in the protocol of the review; clinical experts should be included on the review team; a set of clinical covariates should be chosen considering variables from the participant level, intervention level, outcome level, research setting, or others unique to the research question; covariates should have a clear scientific rationale; there should be a sufficient number of trials per covariate; and results of any such investigations should be interpreted with caution.</p> <p>Conclusions</p> <p>Though the consensus was minimal, there were many recommendations in the literature for investigating clinical heterogeneity in systematic reviews. Formal recommendations for investigating clinical heterogeneity in systematic reviews of controlled trials are required.</p