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Stevens Point, FL, United States

Importance: Vascular endothelial growth factor plays a role in proliferative diabetic retinopathy (PDR). Intravitreal injection of saline has been shown potentially to lead to improved visual acuity compared with observation alone in eyes with vitreous hemorrhage. Therefore, it is important to determine if intravitreal anti-vascular endothelial growth factor can reduce vitrectomy rates (and risks associated with vitrectomy) compared with saline for vitreous hemorrhage from PDR that precludes placement or confirmation of complete panretinal photocoagulation. Objective: To evaluate intravitreal ranibizumab compared with intravitreal saline injections on vitrectomy rates for vitreous hemorrhage from PDR. Design: Phase 3, double-masked, randomized, multicenter clinical trial. Data reported were collected from June 2010 to March 2012 and include 16 weeks of follow-up. Setting: Community-based and academic-based ophthalmology practices specializing in retinal diseases. Participants: Two hundred sixty-one eyes of 261 study participants, who were at least 18 years of age with type 1 or type 2 diabetes mellitus. Study eyes had vitreous hemorrhage from PDR precluding panretinal photocoagulation completion. Intervention: Eyes were randomly assigned to 0.5-mg intravitreal ranibizumab (n=125) or intravitreal saline (n=136) at baseline and 4 and 8 weeks. Main Outcome Measure: Cumulative probability of vitrectomy within 16 weeks. Results: Cumulative probability of vitrectomy by 16 weeks was 12% with ranibizumab vs 17% with saline (difference, 4%; 95% CI, -4% to 13%) and of complete panretinal photocoagulation without vitrectomy by 16 weeks was 44% and 31%, respectively (P=.05). The mean (SD) visual acuity improvement from baseline to 12 weeks was 22 (23) letters and 16 (31) letters, respectively (P=.04). Recurrent vitreous hemorrhage occurred within 16 weeks in 6% and 17%, respectively (P=.01). One eye developed endophthalmitis after saline injection. Conclusions and Relevance: Overall, the 16-week vitrectomy rates were lower than expected in both groups. This study suggests little likelihood of a clinically important difference between ranibizumab and saline on the rate of vitrectomy by 16 weeks in eyes with vitreous hemorrhage from PDR. Short-term secondary outcomes including visual acuity improvement, increased panretinal photocoagulation completion rates, and reduced recurrent vitreous hemorrhage rates suggest biologic activity of ranibizumab. Long-term benefits remain unknown. Whether vitrectomy rates after saline or ranibizumab injection are different than observation alone cannot be determined from this study. © 2013 American Medical Association. All rights reserved. Source

Gal R.L.,Jaeb Center for Health Research
Cochrane database of systematic reviews (Online) | Year: 2012

Optic neuritis is an inflammatory disease of the optic nerve. It occurs more commonly in women than in men. Usually presenting with an abrupt loss of vision, recovery of vision is almost never complete. Closely linked in pathogenesis to multiple sclerosis, it may be the initial manifestation for this condition. In certain patients, no underlying cause can be found. To assess the effects of corticosteroids on visual recovery of patients with acute optic neuritis. We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 1), MEDLINE (January 1950 to February 2012), EMBASE (January 1980 to February 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to February 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 21 February 2012. We also searched reference lists of identified trial reports to find additional trials. We included randomized trials that evaluated corticosteroids, in any form, dose or route of administration, in people with acute optic neuritis. Two authors independently extracted the data on methodological quality and outcomes for analysis. We included six randomized trials which included a total of 750 participants. Two trials evaluated low dose oral corticosteroids while one trial evaluated low dose intravenous corticosteroids across two treatment arms and two trials evaluated a higher dose of intravenous corticosteroids. One three-arm trial evaluated low-dose oral corticosteroids and high-dose intravenous corticosteroids against placebo. Trials evaluating oral corticosteroids compared varying doses of corticosteroids with placebo. Hence, we did not conduct a meta-analysis of such trials. In a meta-analysis of trials evaluating corticosteroids with total dose greater than 3000 mg administered intravenously, the relative risk of normal visual acuity with intravenous corticosteroids compared with placebo was 1.06 (95% confidence interval (CI) 0.89 to 1.27) at six months and 1.06 (95% CI 0.92 to 1.22) at one year. The risk ratio of normal contrast sensitivity for the same comparison was 1.10 (95% CI 0.92 to 1.32) at six months follow up. We did not conduct a meta-analysis for this outcome at one year follow up since there was substantial statistical heterogeneity. The risk ratio of normal visual field for this comparison was 1.08 (95% CI 0.96 to 1.22) at six months and 1.02 (95% CI 0.86 to 1.20) at one year. Quality of life was assessed and reported in one trial. There is no conclusive evidence of benefit in terms of recovery to normal visual acuity, visual field or contrast sensitivity with either intravenous or oral corticosteroids at the doses evaluated in trials included in this review. Source

Gwiazda J.E.,Jaeb Center for Health Research
Investigative Ophthalmology and Visual Science | Year: 2011

PURPOSE. To determine whether progressive-addition lenses (PALs) relative to single-vision lenses (SVLs) slow the progression of low myopia in children with high accommodative lag and near esophoria. METHODS. One hundred eighteen children 8 to <12 years of age with spherical equivalent refraction (SER) from-0.75 to-2.50 D and near esophoria ≥2 PD were enrolled in this double-masked multicenter randomized trial. A key additional eligibility criterion was high accommodative lag, initially defined as at least 0.50 D (accommodative response less than 2.50 D for a 3.00-D demand) and later restricted further to at least 1.00 D. One hundred four subjects had accommodative lag of at least 1.00 D, and 14 had lag between 0.50 and 0.99 D. The children were randomized to receive either PALs with a +2.00-D addition or standard SVLs. The clinicians performing the outcome testing, as well as the children and their families, were masked to treatment group. Follow-up visits occurred every 6 months for 3 years. At annual visits, refractive error was assessed in each eye by using cycloplegic autorefraction. The main outcome measure was change from baseline to 3 years in SER by cycloplegic autorefraction. RESULTS. The mean change in SER between baseline and the 3-year primary outcome visit was-0.87 D in the PAL group and-1.15 D in the SVL group, for a difference of 0.28 D (95% confidence interval [CI], 0.01-0.55D). CONCLUSIONS. The PALs used in this study were found to have a statistically but not clinically significant effect of slowing myopia progression in children with high accommodative lag and near esophoria. © 2011 The Association for Research in Vision and Ophthalmology, Inc. Source

Beck R.W.,Jaeb Center for Health Research
Archives of Ophthalmology | Year: 2011

With the recent increases and future projected increases in the incidence of type 2 diabetes mellitus and with the incidence increasing in teenagers and young adults, the already substantial public health effect of diabetes and diabetic retinopathy will become greater in years to come. Despite the strength of the evidence that optimizing control of glucose, blood pressure, and lipid levels will reduce the incidence and progression of diabetic retinopathy, metabolic control remains suboptimal for many patients with diabetes. In addition, many patients do not follow recommended guidelines for regular eye examinations, which is unfortunate because there is good evidence that with regular follow-up and intervention with photocoagulation as indicated, severe vision loss from diabetic retinopathy is uncommon. Yet, diabetic retinopathy is a leading cause of severe vision loss in adults. The current health care system too often fails to adequately manage diabetes and is lacking in providing proper education and motivation for patients to optimize their metabolic control. In addition to treating retinopathy, ophthalmologists can play an important role in educating and motivating patients to achieve better metabolic control, which, if successful, potentially could do more to reduce the progression of retinopathy than any of the ocular treatments currently in the armamentarium of the ophthalmologist. ©2011 American Medical Association. All rights reserved. Source

Russell S.J.,Massachusetts General Hospital | Beck R.W.,Jaeb Center for Health Research
Diabetes Care | Year: 2016

The development of artificial pancreas systems has evolved to the point that pivotal studies designed to assess efficacy and safety are in progress or soon to be initiated. These pivotal studies are intended to provide the necessary data to gain clearance from the U.S. Food and Drug Administration, coverage by payers, and adoption by patients and clinicians. Although there will not be one design that is appropriate for every system, there are certain aspects of protocol design that will be considerations in all pivotal studies designed to assess efficacy and safety. One key aspect of study design is the intervention to be used by the control group. A case can be made that the control group should use the currently available best technology, which is sensor-augmented pump therapy. However, an equally, if not more, compelling case can be made that the control intervention should be usual care. In this Perspective, we elaborate on this issue and provide a pragmatic approach to the design of clinical trials of artificial pancreas systems. © 2016 by the American Diabetes Association. Source

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