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Biomedical subjects

Brian Levy

Publications and source records attributed to Brian Levy.

12 recordsLinked to original sources
PubMed2006

Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study.

PURPOSE: To report the interim 34-week safety and efficacy results of a 3-year study to evaluate an investigational intravitreal fluocinolone acetonide (FA) implant in patients with noninfectious posterior uveitis. DESIGN: Prospective, dose-masked, dose-randomized, historically controlled, multicenter trial in patients with unilateral or bilateral disease. PARTICIPANTS: A total of 278 patients with recurrent noninfectious posterior uveitis were randomized to receive a 0.59-mg (n = 110) or 2.1-mg (n = 168) implant. In patients with bilateral disease, the more severely affected eye received the implant. METHODS: The implant was inserted surgically into the vitreous cavity through a pars plana incision. Follow-up visits were scheduled on day 2, week 1, and then every 4 to 6 weeks through 34 weeks after implantation. Systemic, periocular, and topical therapies were reduced as allowed by the clinical response. MAIN OUTCOME MEASURES: The primary efficacy outcome was a comparison of the recurrence rate in the implanted eye from the 34 weeks before implantation to the 34 weeks after implantation. Visual acuity (VA), need for adjunctive therapy, and safety also were assessed. RESULTS: Combining both doses, the FA implant reduced the rate of recurrences from 51.4% in the 34 weeks preceding implantation to 6.1% postimplantation (P<0.0001) in the study eyes. Comparatively, there was a significant increase in the recurrence rate in the fellow nonimplanted eyes from 20.3% preimplantation to 42.0% postimplantation (P<0.0001). Visual acuity was stabilized or improved in 87% of implanted eyes and generally was associated with reductions in the area of macular hyperfluorescence. The percentage of eyes that required systemic medications, periocular injections, and topical corticosteroids decreased from 52.9%, 63.0%, and 35.7%, respectively, preimplantation to 12.1%, 2.2%, and 16.5% postimplantation (P< or =0.0001 in all cases). At week 34, 51.1% of implanted eyes required ocular antihypertensive drops, and 5.8% underwent glaucoma filtering surgery. Lens opacity scores increased by > or =2 grades in 19.8% of phakic implanted eyes, and 9.9% required cataract surgery. There were no statistically significant differences in any of the parameters studied for the 0.59-mg implant, compared with the 2.1-mg implant. CONCLUSIONS: The FA implant significantly reduced uveitis recurrences, improved VA, and decreased the need for adjunctive therapy in the studied patient population. The most common side effects included increased intraocular pressure and cataract progression.

Adolescent↗
PubMed2006

Report on testing from an investigation of fusarium keratitis in contact lens wearers.

PURPOSE: Recent reports of disproportionate outbreaks of microbial keratitis caused by Fusarium solani have led to the removal of the Bausch & Lomb multipurpose lens care solution ReNu With MoistureLoc ("MoistureLoc") from the global market. Previous studies have shown an increased risk of contact lens-related corneal infection in connection with overnight wear, noncompliant lens wearing and lens care behaviors, specific treatment regimens, and other patient-related and non-patient-related factors. The purpose of the laboratory evaluations reported in this article were to observe the effects of levels of simulated lens care noncompliance on the antimicrobial efficacy of multipurpose solutions following recent reports of F. solani keratitis. METHODS: Two multipurpose contact lens care solutions, MoistureLoc and ReNu MultiPlus multipurpose solution ("ReNu MultiPlus"), were tested under conditions that attempted to simulate the possible effect of the noncompliant behaviors reported to Bausch & Lomb as part of the investigation into cases of Fusarium keratitis. Testing conditions included simulated multiple reuse of solutions and evaporation of solutions. RESULTS: The biocidal efficacy of MoistureLoc and other tested solutions was reduced under conditions that simulated the possible impact of solution reuse. Further investigation of MoistureLoc and ReNu MultiPlus suggests that although efficacy with ReNu MultiPlus was maintained across a variety of noncompliant conditions, the MoistureLoc formula could be rendered less effective under certain conditions. CONCLUSIONS: Under conditions simulating the possible impact of noncompliance, the MoistureLoc solution showed reduced biocidal efficacy. In contrast, ReNu MultiPlus retained a higher level of biocidal activity under the same conditions.

Contact Lens Solutions↗
PubMed2005

Efficacy and safety of topiramate in the treatment of obese subjects with essential hypertension.

The effect of topiramate on weight and blood pressure (BP) was examined in a randomized, placebo-controlled trial in obese subjects who had hypertension. After a 4-week, placebo, run-in period, 531 obese subjects (body mass index 27 to 50 kg/m(2)) who had established hypertension were randomly assigned to placebo or 96 or 192 mg/day of topiramate. All subjects received a standardized diet, exercise advice, and behavioral modification from run-in through study end. Initially scheduled for 60 weeks on medication, the sponsor ended the study early to develop a new controlled-release formulation. As a consequence, efficacy was assessed within a predefined modified intent-to-treat population (subjects who enrolled early enough to potentially complete 28 weeks on medication). The placebo and 96- and 192-mg groups had respective weight losses of 1.9%, 5.9%, and 6.5% from baseline (p <0.001 for each comparison with placebo) and decreases in diastolic BP of 2.1, 5.5, and 6.3 mm Hg (p <0.015 vs placebo). Systolic BP was decreased by 8.6 and 9.7 mm Hg in the 96- and 192-mg groups and 4.9 mm Hg in the placebo group (p = NS). Compared with placebo, the topiramate groups had larger proportions of subjects whose weight decreased by > or =5% and 10%, whose diastolic BP decreased by > or =5 and 10 mm Hg, and who achieved normalization of BP (BP <130/85 mm Hg). Adverse events included paresthesia, fatigue, taste perversion, loss of appetite, and difficulty with concentration and attention. In conclusion, topiramate produced clinically relevant effects in reducing body weight and BP, with generally mild to moderate adverse effects.

Administration, Oral↗
PubMed2004

Relative primary adhesion of Pseudomonas aeruginosa, Serratia marcescens and Staphylococcus aureus to HEMA-type contact lenses and an extended wear silicone hydrogel contact lens of high oxygen permeability.

PURPOSE: To compare multiple strains of Pseudomonas aeruginosa and representative isolates of Staphylococcus aureus and Serratia marcescens for their relative primary adhesion to a high Dk silicone hydrogel lens (36% H2O) with that of a HEMA-type lens (58% H2O). METHODS: A radiolabeled cell procedure with a 2-h cell exposure was employed for enumerating bacteria on unworn and worn silicone hydrogel (balafilcon A) and HEMA-type (etafilcon A) hydrogel lenses. RESULTS: The degree of primary adhesion of P. aeruginosa to 7-day worn balafilcon A lens was similar to the degree of adhesion to unworn balafilcon A lenses. The degree of primary adhesion by clinical strains to unworn balafilcon A lenses and etafilcon lenses was strain variable, but did not differ markedly for the two lenses with a given strain of P. aeruginosa. Relative to most of the pseudomonad strains, adhesion to the hydrogel lenses by S. aureus and S. marcescens was non-significant. CONCLUSION: Adhesion of strains of P. aeruginosa to a hydrogel contact lens does not appear to differ appreciably between the HEMA-type etafilcon A and the high Dk silicone hydrogel balafilcon A lens.

Journal Article↗
PubMed2004

Topiramate: long-term maintenance of weight loss induced by a low-calorie diet in obese subjects.

OBJECTIVE: To examine the safety and efficacy of topiramate (TPM) for maintaining weight following a low-calorie diet. RESEARCH METHODS AND PROCEDURES: Obese subjects (30 < or = BMI < 50 kg/m(2)) 18 to 75 years old received a low-calorie diet for 8 weeks. Those who lost > or =8% of their initial weight received TPM (96 or 192 mg/d) or placebo; all were on a lifestyle modification plan. Sixty weeks of medication were planned. Sponsor ended study early to develop a new controlled-release formulation with the potential to enhance tolerability and simplify dosing in this patient population. Efficacy was analyzed in subjects who completed 44 weeks of treatment before study termination. RESULTS: Of the 701 subjects enrolled, 80% lost > or =8% of their initial body weight and were randomized; 293 were analyzed for efficacy. Most withdrawals were due to premature termination of the study. Subjects receiving TPM lost 15.4% (96 mg/d) and 16.5% (192 mg/d) of their enrollment weight by week 44, compared with 8.9% in the placebo group (p < 0.001). Subjects on TPM continued to lose weight after the run-in, whereas those on placebo regained weight. Significantly more TPM subjects lost 5%, 10%, or 15% of their randomization weight than placebo. Most adverse events were related to the central nervous system. DISCUSSION: During a treatment period of 44 weeks, TPM was generally well tolerated, and subjects maintained weight loss initially achieved by a low-calorie diet-and produced additional clinically significant weight loss beyond that achieved by a low-calorie diet.

Adolescent↗
PubMed2004

Evolving to clinical terminology.

The electronic medical record (EMR) is slowly replacing the paper chart for documenting patient details. As the adoption curve for EMRs rapidly increases, so will the need for clinical terminologies. Currently, administrative classifications such as ICD-9-CM, CPT and HCPCS serve not only billing and reporting purposes, but also are used by healthcare providers for documentation and capturing patient procedures and problem lists. But the use of clinical terminologies, such as SNOMED CT, will assume the interface role in EMRs and thus replace these administrative classifications at the point of care. These billing terminologies will then be relegated back to the coders and payers for use, enabling the clinicians to document using richer and more granular terminologies. During this transition phase to the clinical terminology, training will likely be required as healthcare providers adjust to using terminologies in more robust ways. Clinical informaticists and early adopters will play a role in this training and help to demonstrate the many advantages of richer documentation. The use of clinical standards in EMRs is one of the key evolutions in informatics.

Diffusion of Innovation↗
PubMed2003

A randomized trial of rigid gas permeable contact lenses to reduce progression of children's myopia.

PURPOSE: To test whether rigid gas permeable (RGP) contact lens wear can reduced the rate of myopia progression in school age children. DESIGN: Randomized clinical trial. METHODS SETTING: Single clinical center. STUDY POPULATION: Both eyes of 428 Singaporean children. INCLUSION CRITERIA: 6 through 12 years of age with myopia between -1 and -4 diopters, astigmatism <or= 2 diopters, no prior contact lens wear, no other ocular pathologies. INTERVENTION: Spectacle or RGP lens correction for myopia. After a 3-month adaptation period, 383 children were followed, and 298 (78%) remained after 24 months. OUTCOME MEASURES: Cycloplegic subjective refraction, keratometry, and axial length measured at 12 and 24 months. RESULTS: Children who adapted to contact lenses wore them for a median of 7 hours per day, but no more than 40% wore them at least 8 hours per day, 7 days per week. Spectacles were worn for a median of 15 hours per day at the time of the 24-month follow-up. There was an increase in the spherical equivalent of -1.33 and -1.28 diopters (P =.64), and axial length increased by 0.84 and 0.79 mm (P =.38) over 2 years among children randomized to contact lenses and spectacles, respectively. Adjustment for baseline differences between the groups and for hours per day of contact lens wear did not alter these findings. CONCLUSIONS: Rigid gas permeable lenses did not slow the rate of myopia progression, even among children who used them regularly and consistently. It is unlikely that this intervention holds promise as a method by which to slow the rate of progression of myopia in children.

Child↗
PubMed2003

A 6-month randomized, placebo-controlled, dose-ranging trial of topiramate for weight loss in obesity.

OBJECTIVE: To evaluate the efficacy and safety of topiramate (TPM) for weight loss in healthy obese subjects. RESEARCH METHODS AND PROCEDURES: A randomized, double-blind, placebo-controlled, dose-ranging trial was conducted. Three hundred eighty-five subjects, 18 and 75 years of age, were randomized to receive either placebo or TPM at 64, 96, 192, or 384 mg daily. Dosing began at 16 mg once daily. In week 2, the dose was increased to 16 mg twice daily. Thereafter, the dose was raised every week by 32 mg/d (16 mg twice daily) until subjects reached their target dose. Twenty-four weeks after beginning treatment, all subjects were tapered off treatment by a dose reduction of 50% per week. All participants received the same lifestyle program. RESULTS: Mean percent weight loss from baseline to week 24 was -2.6% in placebo-treated patients vs. -5.0%, -4.8%, -6.3%, and -6.3% in the 64, 96, 192, and 384 mg/d TPM groups, respectively. Greater percentages of TPM-treated patients lost at least 5% or 10% of body weight compared with placebo. The most frequent adverse events were related to the central or peripheral nervous system, including paresthesia, somnolence, and difficulty with memory, concentration, and attention. Most events were dose-related, occurred early in treatment, and usually resolved spontaneously; only 21% receiving TPM withdrew due to adverse events compared with 11% on placebo. DISCUSSION: TPM produced significantly greater weight loss than placebo at all doses.

Adolescent↗
PubMed2002

Enzymatic sclerostomy: pilot human study.

OBJECTIVE: To evaluate the feasibility and safety of enzymatic sclerostomy as a new modality to lower intraocular pressure in patients with open-angle glaucoma. METHODS: This single-center, prospective, noncomparative, interventional case series included 15 blind symptomatic eyes of 15 patients with primary open-angle glaucoma. Enzymatic sclerostomy was performed with the patient under topical or peribulbar anesthesia. A specially designed polymethylmethacrylate enzyme applicator filled with a mean +/- SD of 123 +/- 13 microg of collagenase was introduced through a 5-mm peritomy, and affixed to the limbus by means of cyanoacrylate tissue glue. After 22 to 24 hours, the applicators were removed and the patients were followed up for 1 year. Intraocular pressure changes from baseline and complications related to the procedure were the main outcome measures. RESULTS: Controlled thinning of the treated sclera associated with aqueous percolation and shallow filtration bleb was seen in all eyes in the immediate postoperative period. The mean +/- SD intraocular pressure decreased from 43.5 +/- 9.8 mm Hg (while the patients were receiving a mean +/- SD of 1.75 +/- 0.75 antiglaucoma medications) preoperatively to 24.8 +/- 10.6 mm Hg (a 43.0% decrease from baseline with no antiglaucoma medication) on the first postoperative day and to 34.8 +/- 10.5 mm Hg (a 20.0% decrease from baseline with no antiglaucoma medication) at the end of 1 year. Ophthalmic adverse effects were limited to the treated area and included immediate postoperative transient conjunctival reaction ranging from mild chemosis to conjunctival maceration. Immediate full-thickness perforation developed in 1 eye; the patient was treated and excluded from data analysis. Two eyes developed symptoms related to increase in intraocular pressure after 9 months; the patients were treated and excluded from further data analysis. No systemic complications were noted. CONCLUSIONS: Enzymatic sclerostomy demonstrated immediate and sustained intraocular pressure reduction and provided symptomatic relief in blind eyes with primary open-angle glaucoma. The procedure, however, needs further technical refinement.

Aged↗
PubMed2002

A 1-year prospective clinical trial of balafilcon a (PureVision) silicone-hydrogel contact lenses used on a 30-day continuous wear schedule.

PURPOSE: To evaluate silicone-hydrogel balafilcon A (PureVision, Bausch & Lomb Inc., Rochester, NY) contact lenses worn on a 30-day continuous wear basis when compared with a traditional hydrogel (Acuvue, Vistakon, Johnson and Johnson Vision Products, Inc., Jacksonville, FL) worn on a 7-day extended wear schedule. DESIGN: Prospective, comparative, paired-eye, interventional, multicenter clinical trial. PARTICIPANTS: Two hundred twelve ametropes with no significant ocular pathology. METHODS: Subjects with normal ocular health who conformed to a set of standard criteria were monitored at seven different sites around the globe. Subjects wore both study lenses simultaneously, one on each eye. Lenses were assigned to right and left eyes according to a randomized schedule. The silicone hydrogel was removed and replaced every month and the traditional hydrogel was removed every 7 days and replaced at 14-day intervals. Subjects were followed for up to 1 year with discontinuation on indication divided between lens-related causes, unrelated factors, and loss to follow-up. MAIN OUTCOME MEASURES: Discontinuations, symptoms, vision, lens fit, lens surface assessment, slit-lamp assessment, and patient preferences. RESULTS: One hundred twenty three subjects completed the 12-month wearing period. There were no vision-threatening events with either lens type. The silicone-hydrogel lenses showed statistically superior performance in physiologic terms with regard to epithelial microcysts, striae, corneal staining, limbal injection, and bulbar injection. Inflammatory reactions, such as corneal infiltrates and tarsal conjunctival abnormalities occurred at similar rates between the lens types. Visible deposition and postlens debris with associated transient corneal indentation were significantly lower with the traditional hydrogel material at specific time points in the study. Visual acuity was comparable with the two lens types. Subjects rated the silicone-hydrogel material as preferable on subjective scales of dryness, comfort, and lens handling. Overall subjective performance was rated superior with the silicone-hydrogel material. CONCLUSIONS: The high oxygen performance of the silicone-hydrogel lenses provides a superior physiologic environment compared with a traditional hydrogel material during continuous wear. Despite the slightly higher levels of visible deposit on the silicone-hydrogels, superior subjective responses suggest that the plasma coating technology on these lenses is effective in providing comfortable lens wear. The results look promising for the success of silicone-hydrogels as the material of choice for continuous wear contact lenses.

Adolescent↗