Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations

Purpose: We assessed the safety and efficacy of a technically advanced subretinal electronic implant, RETINA IMPLANT Alpha AMS, in end stage retinal degeneration in an interim analysis of two ongoing prospective clinical trials. The purpose of this article is to describe the interim functional results (efficacy). Methods: The subretinal visual prosthesis RETINA IMPLANT Alpha AMS (Retina Implant AG, Reutlingen, Germany) was implanted in 15 blind patients with hereditary retinal degenerations at four study sites with a follow-up period of 12 months (www.clinicaltrials.gov NCT01024803 and NCT02720640). Functional outcome measures included (1) screen-based standardized 2- or 4-alternative forced-choice (AFC) tests of light perception, light localization, grating detection (basic grating acuity (BaGA) test), and Landolt C-rings; (2) gray level discrimination; (3) performance during activities of daily living (ADL-table tasks). Results: Implant-mediated light perception was observed in 13/15 patients. During the observation period implant mediated localization of visual targets was possible in 13/15 patients. Correct grating detection was achieved for spatial frequencies of 0.1 cpd (cycles per degree) in 4/15; 0.33 cpd in 3/15; 0.66 cpd in 2/15; 1.0 cpd in 2/15 and 3.3 cpd in 1/15 patients. In two patients visual acuity (VA) assessed with Landolt C- rings was 20/546 and 20/1111. Of 6 possible gray levels on average 4.6 ± 0.8 (mean ± SD, n = 10) were discerned. Improvements (power ON vs. OFF) of ADL table tasks were measured in 13/15 patients. Overall, results were stable during the observation period. Serious adverse events (SAEs) were reported in 4 patients: 2 movements of the implant, readjusted in a second surgery; 4 conjunctival erosion/dehiscence, successfully treated; 1 pain event around the coil, successfully treated; 1 partial reduction of silicone oil tamponade leading to distorted vision (silicon oil successfully refilled). The majority of adverse events (AEs) were transient and mostly of mild to moderate intensity. Conclusions: Psychophysical and subjective data show that RETINA IMPLANT Alpha AMS is reliable, well tolerated and can restore limited visual functions in blind patients with degenerations of the outer retina. Compared with the previous implant Alpha IMS, longevity of the new implant Alpha AMS has been considerably improved. Alpha AMS has meanwhile been certified as a commercially available medical device, reimbursed in Germany by the public health system

Peripheral defocus does not necessarily affect central refractive development

AbstractPurpose.Recent experiments in monkeys suggest that deprivation, imposed only in the periphery of the visual field, can induce foveal myopia. This raises the hypothesis that peripheral refractive errors imposed by the spectacle lens correction could influence foveal refractive development also in humans. We have tested this hypothesis in chicks.Methods.Chicks wore either full field spectacle lenses (+6.9 D/−7 D), or lenses with central holes of 4, 6, or 8mm diameter, for 4 days (n=6 for each group). Refractions were measured in the central visual field, and at −45° (temporal) and +45° (nasal), and axial lengths were measured by A-scan ultrasonography.Results.As previously described, full field lenses were largely compensated within 4 days (refraction changes with positive lenses: +4.69±1.73 D, negative lenses: −5.98±1.78 D, both p<0.001, Dunnett’s test, to untreated controls). With holes in the center of the lenses, the central refraction remained emmetropic and there was not even a trend of a shift in refraction (all groups: p>0.5, Dunnetts test). At ±45°, the lenses were partially compensated despite the 4/6/8mm central holes; positive lenses: +2.63 / +1.44 / +0.43 D, negative lenses: −2.57 / −1.06 / +0.06 D.Conclusions.There is extensive local compensation of imposed refractive errors in chickens. For the tested hole sizes, peripherally imposed defocus did not influence central refractive development. To alter central refractive development, the unobstructed part in the central visual field may have to be quite small (hole sizes smaller than 4mm, with the lenses at a vertex distance of 2–3mm)

Myopia: Why study the mechanisms of myopia? Novel approaches to risk factors signalling eye growth- how could basic biology be translated into clinical insights? Where are genetic and proteomic approaches leading? How does visual function contribute to and interact with ametropia? Does eye shape matter? Why ametropia at all?

On July 26-29, 2010 the 13th International Myopia Conference was held in Tübingen, Germany and included 17 separate symposia, each with 3-5 presentations. Here, in a single paper, the chairs of those Symposia describe the scientific advances noted at the conference and include the full abstracts of the individual myopia papers presented in each symposium along with the authors and their institutions. The 17 Symposia covered 7 topics: Why Study the Mechanisms of Myopia?; Novel Approaches to Risk Factors; Signalling Eye Growth- How Could Basic Biology Be Translated into Clinical Insights?; Where Are Genetic and Proteomic Approaches Leading?; How Does Visual Function Contribute to and Interact with Ametropia?; Does Eye Shape Matter?; Why Ametropia at All