Glaucoma is the second leading cause of blindness with ∼70 million people worldwide who are blind from this disease. The currently practiced trabeculectomy surgery, the gold standard treatment used to stop the progression of vision loss, is rather draconian, traumatic to the patient and requires much surgical skill to perform. This article summarizes the more than 10‐year development path of a novel device called the InnFocus MicroShunt®, which is a minimally invasive glaucoma drainage micro‐tube used to shunt aqueous humor from the anterior chamber of the eye to a flap formed under the conjunctiva and Tenon's Capsule. The safety and clinical performance of this device approaches that of trabeculectomy. The impetus to develop this device stemmed from the invention of a new biomaterial called poly(styrene‐block‐isobutylene‐block‐styrene), or “SIBS.” SIBS is ultra‐stable with virtually no foreign body reaction in the body, which manifests in the eye as clinically insignificant inflammation and capsule formation. The quest for an easier, safer, and more effective method of treating glaucoma led to the marriage of SIBS with this glaucoma drainage micro‐tube. This article summarizes the development of SIBS and the subsequent three iterations of design and four clinical trials that drove the one‐year qualified success rate of the device from 43% to 100%. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 211–221, 2017.
Objective To evaluate the association of subretinal hyper-reflective material (SHRM) with visual acuity (VA), geographic atrophy (GA) and scar in the Comparison of Age related Macular Degeneration Treatments Trials (CATT) Design Prospective cohort study within a randomized clinical trial. Participants The 1185 participants in CATT. Methods Participants were randomly assigned to ranibizumab or bevacizumab treatment monthly or as-needed. Masked readers graded scar and GA on fundus photography and fluorescein angiography images, SHRM on time domain (TD) and spectral domain (SD) optical coherence tomography (OCT) throughout 104 weeks. Measurements of SHRM height and width in the fovea, within the center 1mm2, or outside the center 1mm2 were obtained on SD-OCT images at 56 (n=76) and 104 (n=66) weeks. VA was measured by certified examiners. Main Outcome Measures SHRM presence, location and size, and associations with VA, scar, and GA. Results Among all CATT participants, the percentage with SHRM at enrollment was 77%, decreasing to 68% at 4 weeks after treatment and 54% at 104 weeks. At 104 weeks, scar was present more often in eyes with persistent SHRM than eyes with SHRM that resolved (64% vs. 31%; p<0.0001). Among eyes with detailed evaluation of SHRM at weeks 56 (n=76) and 104 (n=66), mean [SE] VA letter score was 73.5 [2.8], 73.1 [3.4], 65.3 [3.5], and 63.9 [3.7] when SHRM was absent, present outside the central 1mm2, present within the central 1mm2 but not the foveal center, or present at the foveal center (p=0.02). SHRM was present at the foveal center in 43 (30%), within the central 1mm2 in 21 (15%) and outside the central 1mm2 in 19 (13%). When SHRM was present, the median maximum height in microns under the fovea, within the central 1 mm2 including the fovea and anywhere within the scan was 86; 120; and 122, respectively. VA was decreased with greater SHRM height and width (p<0.05). Conclusions SHRM is common in eyes with NVAMD and often persists after anti-VEGF treatment. At 2 years, eyes with scar were more likely to have SHRM than other eyes. Greater SHRM height and width were associated with worse VA. SHRM is an important morphological biomarker in eyes with NVAMD.
An association has been noted between the presence of alexithymic characteristics and psychosomatic/stress-related illness. A hypothesis is presented here outlining the mechanisms through which stress and alexithymic characteristics contribute to the development of stress-related illness. This hypothesis, the stress-alexithymia hypothesis, is considered here in the context of stress research from both theoretical and empirical perspectives. From these considerations, it appears that the stress-alexithymia hypothesis does have a theoretical basis. Additionally, there is indirect empirical evidence supporting the proposed influence of alexithymic characteristics on the physiological stress response. It is suggested that future research should directly examine the influence of alexithymic characteristics on stress responding and use alexithymic characteristics heuristically to explore the role of affect in the illness process.
The InnFocus MicroShunt® is a minimally invasive glaucoma drainage microtube used to shunt aqueous humor from the anterior chamber of the eye to a flap formed under the conjunctiva and Tenon’s capsule. The safety and clinical performance of this device approaches that of trabeculectomy with mitomycin C, the current ‘gold standard’ treatment for advanced glaucoma. The invention of a new biomaterial called poly(styrene-block-isobutylene-block-styrene) or ‘SIBS’ is the enabling factor which led to the success of this product. SIBS is ultrastable with virtually no foreign body reaction in the body, which manifests as clinically insignificant inflammation and capsule formation in the eye. The lack of capsule formation enables unobstructed flow through the 70 µm lumen tube and the achievement of controlled low intraocular pressure, which is important for the management of glaucoma. This article summarizes the integration of SIBS into a glaucoma drainage device and confirms its functionality with clinical success over a 2-year period.
Individual differences in response to stress have been linked to the development of stress-related disorders through the presence of a dissociation between physiological and subjective stress responses. It has been suggested that the presence of alexithymic characteristics may constitute a new source of individual response differences and thereby contribute to the development of a stress-related disorder. However, it is also possible that the presence of alexithymic characteristics is simply a new name for a preexisting construct. The present study examined subjective and physiological stress response patterns in normal individuals with high or low presence of alexithymic characteristics, and the relationship between alexithymia and potentially equivalent constructs. The results revealed that the presence of alexithymic characteristics is independent of repression, trait anxiety, and social desirability. As well, high alexithymics appear to manifest high levels of sympathetic activity, and a dissociation between subjective and physiological stress responses. These results are discussed in terms of the potential contribution of alexithymic characteristics to the development of stress-related disorders.
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