Randomized clinical trial of a new dexamethasone delivery system (Surodex) for treatment of post-cataract surgery inflammation

OBJECTIVE: To evaluate the safety of Surodex Drug Delivery System (Oculex Pharmaceuticals, Inc., Sunnyvale, CA) containing dexamethasone 60 micrograms, for use in cataract surgery, and to compare its anti-inflammatory efficacy with conventional dexamethasone 0.1% eyedrops. DESIGN: Randomized, masked, and partially controlled trial. PARTICIPANTS: Sixty eyes of 60 Asian patients undergoing extracapsular cataract extraction with intraocular lens implantation were examined. Of these, 28 eyes of 28 patients served as control eyes. Patients were stratified for age and presence of diabetes mellitus. INTERVENTION: Surodex was inserted in the anterior chamber of 32 eyes at the conclusion of surgery. These eyes received placebo eyedrops four times a day after surgery for 4 weeks. Control eyes received neither Surodex nor a placebo implant but were prescribed conventional 0.1% dexamethasone eyedrops four times a day for 4 weeks. MAIN OUTCOME MEASURES: Anterior chamber cells and flare were clinically graded at the slit lamp. Anterior chamber flare was objectively assessed with the Kowa FM500 Laser Flare Meter (Kowa Co. Ltd, Tokyo, Japan) for up to 3 months after surgery. Intraocular pressure and corneal endothelial specular microscopy with morphometric cell analysis were performed for up to 1 year after surgery. RESULTS: Clinical slit-lamp assessment of anterior chamber flare and cells showed no difference between Surodex-treated eyes and dexamethasone eyedrop-treated eyes. Flare meter readings showed lower flare levels in the Surodex group at all postoperative visits compared with the dexamethasone eyedrop group. Flare reduction in the Surodex group reached statistical significance at days 4, 8, 15, and 30 after surgery. At 3 months, flare was reduced to preoperative levels in the Surodex group but was still raised in the dexamethasone eyedrop group. Five eyes in the dexamethasone eyedrop group required augmentation of steroids and were deemed therapeutic failures as opposed to one eye in the Surodex group. One patient in the dexamethasone eyedrop group developed postoperative open-angle glaucoma with profound visual field loss and optic disc cupping, resulting in hand movements vision. No significant difference in endothelial cell loss was noted between Surodex-inserted eyes and dexamethasone eyedrop-treated eyes for up to 1 year after surgery. CONCLUSIONS: Intraocular placement of a single Surodex is a safe and effective treatment method to reduce intraocular inflammation after cataract surgery. There was no statistical difference in efficacy between Surodex and 0.1% dexamethasone eyedrops in reducing intraocular inflammation, as measured by clinical methods, while Surodex was clearly superior to eyedrops in reducing aqueous flare as objectively assessed with the laser flare meter.     

Prospective, randomized vector analysis of astigmatism after three-, one-, and no-suture phacoemulsification

PURPOSE: To compare surgically induced astigmatism and visual outcomes after three-, one-, and no-suture phacoemulsification. SETTING: Johns Hopkins Hospital, Baltimore, Maryland and Manhattan Eye, Ear, and Throat Hospital, New York, New York, USA. METHODS: This prospective, randomized study followed 131 patients treated with phacoemulsification with a 5.5 mm self-sealing scleral tunnel and implantation of a 5.5 mm poly(methyl methacrylate) posterior chamber lens. Radial 10-0 nylon sutures were used in the three- and one-suture groups. RESULTS: Mean astigmatism was greatest in the first postoperative week in all groups and stabilized after 8 weeks. The percentage of patients with with-the-rule (WTR) astigmatism increased from baseline in the one- and three-suture groups and decreased in the sutureless group. Mean uncorrected Snellen acuity was significantly better in the no- and one-suture groups than in the three-suture group at 1 week. There were no significant differences in uncorrected acuity at other times. No statistically significant differences in the surgically induced spherical equivalent were noted among the three groups during the 1 year follow-up. There was significantly less surgically induced keratometric astigmatism in the one-suture group at 4 (P = .03) and 8 (P = .007) weeks postoperatively. At all follow-ups, the sutureless group had the greatest proportion of patients, with significant ATR astigmatic shift (1 week, 17%; 4 weeks, 32%); and the lowest proportion of patients with significant WTR astigmatic shift (10% after 1 week). At 4 weeks, the percentage of patients with significant WTR shift in the one-suture group dropped to that in the sutureless group (10%); however, those in the one-suture group had less ATR astigmatic shift (16%). CONCLUSION: Sutureless and one-suture surgery resulted in a low percentage of WTR induced astigmatism 4 weeks postoperatively. Compared with sutureless surgery, the one-suture surgery resulted in less ATR shift.     

Endogenous ascorbate regenerates vitamin E in the retina directly and in combination with exogenous dihydrolipoic acid

An in vitro neonatal rat preparation, consisting of the isolated caudal brainstem and stomach joined by the intact vagi, was developed using Sprague-Dawley rats. The animals were 0 to 4 days of age. This preparation provided an opportunity to investigate the extracellular and intracellular responses of neurons in the nucleus tractus solitarius (NTS) of the brainstem to electrical stimulation of subdiaphragmatic vagal fibers. The dorsal and ventral vagal branches were electrically stimulated at the point of the common subdiaphragmatic vagal trunk. The isolated preparation was superfused in a recording chamber at 28 degrees C with a modified Krebs solution, equilibrated with 95% O2 and 5% CO2. Suction microelectrodes, for electrical stimulation, were positioned on the common vagal trunk just below the diaphragm to evaluate extracellular and intracellular evoked responses in NTS. A total of 204 subdiaphragmatic vagally-evoked (SDVe) brainstem unitary responses in the NTS were recorded. The mean latency of the extracellular SDVe brainstem responses was 89 +/- 12.9 ms (mean +/- SD). The peripheral gastric effects of CCK-8 on SDVe unitary responses in NTS neurons were evaluated. The peptide caused a significant increase in the excitability of these NTS neurons which was blocked by the CCKA receptor antagonist L-364,718. Neurons in the NTS and the dorsal motor nucleus of the vagus which showed excitatory responses to vagal stimulation were filled with Lucifer Yellow to evaluate their morphology.     

Orifice-view aortography in patients with congenitally deformed aortic valves: determination of aortic valve area

Reports from the United States and around the world have marked a steadily rising cesarean section rate. Although the indications that account for the increase are generally agreed upon (previous cesarean section, dystocia, fetal distress, and malpresentation), the benefits derived from the liberalized use of cesarean section to deal with these diagnoses have not been carefully documented. In an attempt to determine if the cesarean section rate could be lowered with no adverse effect on neonatal outcome, 105,848 deliveries at Downstate-Kings County Hospital from 1961 through 1977 were reviewed. The 9727 cesarean sections performed were evaluated to determine the reasons for the increasing rates and the effect on perinatal outcome. It was concluded that by the use of fetal scalp blood sampling in cases of fetal distress, the use of internal pressure transducers in patients who fail to progress in labor, and allowing selected patients with previous sections to labor, the cesarean section rate might be substantially lowered. The maternal morbidity and mortality were also analyzed.     

XYL, a nonconjugative xylene-degradative plasmid in Pseudomonas Pxy

Pseudomanas Pxy metabolizes p- or m-xylene through intermediate formation of the corresponding methylbenzyl alcohol and toluic acid via the meta pathway. The strain Pseudomonas Pxy spontaneously loses its ability to grow with xylene or toluate, and the rate of loss of this ability is greatly enhanced by treatment of the cells with mitomycin C. The assay of enzymes involved in xylene degradation in xylene-negative Pxy cells indicates the loss of the entire enzyme complement of the pathway. The genes specifying all the xylene-degradative enzymes, including those of the meta pathway, appear to be borne on a nonconjugative plasmid and can be transferred to xylene-negative Pxy or P. putida strain PpG1 cells only in the presence of a transfer plasmid termed factor K. When transferred to strain PpG1, the xylene-degradative plasmid, termed XYL, coexists stably with factor K, but transduction of XYL is not accompanied by a cotransfer of factor K. XYL appears to be compatible wit- all the other known degradative plasmids in P. putida. The xylene pathway is inducible in wild-type Pxy as well as in Pxy and PpG1 exconjugants, suggesting the cotransfer of regulatory genes along with the plasmid. The enzymes converting xylene to toluate are induced by xylene, methylbenzyl alcohol, or the aldehyde derivatives but not significantly by toluate, whereas catechol dioxygenase and other enzymes are induced by toluates and presumable by xylene as well.     

Clinical assessment of left ventricular regional contraction patterns and ejection fraction by high-resolution gated scintigraphy

An improved, noninvasive, radionuclidic, gated blood-pool imaging technique has been developed for clinical analysis of regional contraction abnormalities of the left ventricle and determination of ejection fraction. The principal innovations include high-resolution collimation, higher information density, improved method for dynamic aortic-mitral-diaphragmatic border delineation, accurate selection of the endsystolic gating interval through the use of the phonocardiogram, and accurate end-diastole by on-line gating immediately following the electrocardiographic QRS. The results of scintigraphic studies were compared with selective radiopaque cineangiographic findings in 27 patients with cardiac disease; excellent correlations of ejection fractions (r = 0.93) and abnormal contraction patterns (17/17 patients) were demonstrated. In addition, the clinical usefulness in evaluating ventricular performance was demonstrated in 79 patients with acute and chronic coronary artery disease. This radionuclidic technique allowed assessment of reversibility of segmental dyssynergy by the response to nitroglycerin in 20 patients. These findings demonstrate the validity of this improved radionuclidic technique in the atraumatic quantification of ventricular function and suggest its usefulness in a variety of clinical conditions.