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Cleveland, OH, United States

Freedman S.F.,Duke University | Lynn M.J.,Emory University | Beck A.D.,Emory University | Bothun E.D.,University of Minnesota | And 2 more authors.
JAMA Ophthalmology | Year: 2015

IMPORTANCE: Glaucoma-related adverse events constitute major sight-threatening complications of cataract removal in infancy, yet their relationship to aphakia vs primary intraocular lens (IOL) implantation remains unsettled. OBJECTIVE:To identify and characterize cases of glaucoma and glaucoma-related adverse events (glaucoma + glaucoma suspect) among children in the Infant Aphakia Treatment Study by the age of 5 years. DESIGN, SETTING, AND PARTICIPANTS:A multicenter randomized clinical trial of 114 infants with unilateral congenital cataract in referral centers who were between ages 1 and 6 months at surgery. Mean follow-up was 4.8 years. This secondary analysis was conducted from December 23, 2004, to November 13, 2013. INTERVENTIONS:Participants were randomized at cataract surgery to either primary IOL or no IOL implantation (contact lens). Standardized definitions of glaucoma and glaucoma suspect were created for the Infant Aphakia Treatment Study and applied for surveillance and diagnosis. MAIN OUTCOMES AND MEASURES:Development of glaucoma and glaucoma + glaucoma suspect in operated on eyes for children up to age 5 years, plus intraocular pressure, visual acuity, and axial length at age 5 years. RESULTS:Product limit estimates of the risk for glaucoma and glaucoma + glaucoma suspect at 4.8 years after surgery were 17%(95%CI, 11%-25%) and 31% (95%CI, 24%-41%), respectively. The contact lens and IOL groups were not significantly different for either outcome: glaucoma (hazard ratio [HR], 0.8; 95%CI, 0.3-2.0; P = .62) and glaucoma + glaucoma suspect (HR, 1.3; 95%CI, 0.6-2.5; P = .58). Younger (vs older) age at surgery conferred an increased risk for glaucoma (26%vs 9%, respectively) at 4.8 years after surgery (HR, 3.2; 95%CI, 1.2-8.3), and smaller (vs larger) corneal diameter showed an increased risk for glaucoma + glaucoma suspect (HR, 2.5; 95%CI, 1.3-5.0). Age and corneal diameter were significantly positively correlated. Glaucoma was predominantly open angle (19 of 20 cases, 95%), most eyes received medication (19 of 20, 95%), and 8 of 20 eyes (40%) underwent surgery. CONCLUSIONS AND RELEVANCE:These results suggest that glaucoma-related adverse events are common and increase between ages 1 and 5 years in infants after unilateral cataract removal at 1 to 6 months of age; primary IOL placement does not mitigate their risk but surgery at a younger age increases the risk. Longer follow-up of these children may further characterize risk factors, long-term outcomes, potential differences between eyes having primary IOL vs aphakia, and optimal timing of unilateral congenital cataract removal. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00212134.

Raffay T.M.,Rainbow Hospitals | Martin R.J.,Rainbow Hospitals | Reynolds J.D.,Case Western Reserve University | Reynolds J.D.,Case Medical Center University Hospitals
Clinics in Perinatology | Year: 2012

A growing understanding of endogenous nitric oxide (NO) biology is helping to explain how and when exogenous NO may confer benefit or harm; this knowledge is also helping to identify new better-targeted NO-based therapies. In this review, results of the bronchopulmonary dysplasia clinical trials that used inhaled NO in the preterm population are placed in context, the biologic basis for novel NO therapeutics is considered, and possible future directions for NO-focused clinical and basic research in developmental lung disease are identified. © 2012 Elsevier Inc.

Schroeder C.,University Hospitals | Hejal R.,Case Medical Center University Hospitals | Linden P.A.,University Hospitals
Journal of Thoracic and Cardiovascular Surgery | Year: 2010

Objectives: CyberKnife stereotactic body radiosurgery is a potentially curative option for medically inoperable Stage I lung cancer. Fiducial marker placement in or near the tumor is required. Transthoracic placement using computed tomography guidance has been associated with a high risk of iatrogenic pneumothorax. Electromagnetic navigation bronchoscopy offers a safer method of placing markers; however, previous studies using linear markers have shown at least a 10% dislocation rate. We describe the use of coil-spring fiducial markers placed under moderate sedation in an outpatient bronchoscopy suite. Methods: A total of 52 consecutive nonoperative patients with isolated lung tumors underwent fiducial placement using electromagnetic navigation bronchoscopy. Of the 52 patients, 4 received 17 linear fiducial markers, and 49 patients with 56 tumors received 217 coil-spring fiducial markers. The procedures were considered successful if the fiducial markers had been placed in or near the tumors and had remained in place without migration, allowing radiosurgery without the need for additional fiducial markers. Results: A total of 234 fiducial markers were successfully deployed in 52 patients with 60 tumors (mean diameter 23.7 mm). Of these 60 tumors, 35 (58%) were adjacent to the pleura. At CyberKnife planning, 8 (47%) of 17 linear fiducial markers and 215 (99%) of 217 coil-spring fiducial markers (P = .0001) were still in place. Of the 4 patients with linear fiducial markers, 2 required additional fiducial placements; none of the patients with coil fiducial markers required additional procedures. Three pneumothoraces (5.8%) occurred in peripheral lesions (2 were treated with a pig-tail chest tube and 1 with observation only). Conclusions: Deployment of coil spring fiducial markers using navigation bronchoscopy can safely be performed with the patient under moderate sedation with almost no migration and a 5.8% rate of pneumothorax. © 2010 by The American Association for Thoracic Surgery.

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