Search results for "Randomized controlled"
showing 10 items of 2220 documents
A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma
2014
Purpose To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG). Design Prospective, multicenter, randomized, single-masked, controlled clinical trial. Participants One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP (DIOP) of 21 to 36 mmHg. Methods On the day of surgery, patients were randomized 1:1 to undergo CS with the microstent or CS alone. Postoperative follow-up was at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months. Wa…
Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocul…
2019
UNLABELLED: PRéCIS:: Noninferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared with a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension. PURPOSE: The purpose of this study was to compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension. METHODS: Phase III, randomized, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged 18 years or older with o…
Randomized Trial of Brinzolamide/Brimonidine Versus Brinzolamide Plus Brimonidine for Open-Angle Glaucoma or Ocular Hypertension
2014
Introduction Fixed-combination intraocular pressure (IOP)—lowering medications simplify treatment regimens for patients requiring 2 ocular hypotensive agents to maintain sufficiently low IOP. The aim of this study was to evaluate the safety and efficacy of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) versus concomitant administration of brinzolamide 1% plus brimonidine 0.2% (BRINZ + BRIM) in patients with open-angle glaucoma or ocular hypertension. Methods This was a prospective, phase 3, multicenter, double-masked, 6-month trial. Patients who had insufficient IOP control with monotherapy or who were receiving 2 IOP-lowering medications were randomized 1:1 to receive twice-dail…
Deep sclerectomy versus trabeculectomy with low-dosage mitomycin C: four-year follow-up
2006
<i>Aims:</i> To compare the long-term effects of low-dosage mitomycin C (MMC) in both deep sclerectomy (DSMMC) and trabeculectomy (TPMMC) on intraocular pressure (IOP). <i>Methods:</i> Analysis of extended follow-up of data from a prospective clinical trial. Forty patients were originally randomised to undergo either DSMMC (19 eyes) or TPMMC (21 eyes). Follow-up was performed at postoperative day 1, weeks 1, 2 and 3, as well as months 1, 3, 6, 9, 12, 18, 24, 36 and 48. Two- to three-week data were not included in the statistical analysis. Postoperative complications, number of antiglaucoma medications and IOP were recorded at each visit. Complete (no medications) and…
E-PTFE (Gore-Tex) implant with or without low-dosage mitomycin-C as an adjuvant in penetrating glaucoma surgery: 2 year randomized clinical trial.
2008
Purpose: To test the expanded polytetrafluoroethylene (ePTFE) as a new adjuvant in trabeculectomy. Methods: Consecutive glaucoma surgical inpatients were observed at the Department of Ophthalmology of Palermo University. Sixty patients (60 eyes) were randomly assigned to undergo trabeculectomy (T), trabeculectomy with mitomycin-C (TMMC), with ePTFE (TG) or with mitomycin-C and ePTFE (TGMMC). Postoperative visits were scheduled at 24 hr, 7 days, 1, 3, 6, 12, 18 and 24 months. Complete success and qualified success were assessed at two target intraocular pressure (IOP) levels – £21 and £17 mmHg – by Kaplan–Meier curves. Results: The postoperative IOP reduction was significant (P < 0.01) at th…
Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial
2011
AIM: To verify the safety and efficacy of Ologen (OLO) implant as adjuvant compared with low-dosage mitomycin-C (MMC) in trabeculectomy. METHODS: This was a prospective randomized clinical trial with a 24-month follow-up. Forty glaucoma patients (40 eyes) were assigned to trabeculectomy with MMC or OLO. Primary outcome includes target IOP at ≤21, ≤17, and ≤15 mm Hg; complete (target IOP without medications), and qualified success (target IOP regardless of medications). Secondary outcomes include bleb evaluation, according to Moorfields Bleb Grading System (MBGS); spectral domain optical coherence tomography (SD-OCT) examination; number of glaucoma medications; and frequency of postoperative…
Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain
2015
Background Combination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective. Methods This was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen trometamol (12.5 mg and 25 mg) and tramadol hydrochloride (37.5 mg and 75 mg), given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objecti…
Preoperative pain neuroscience education combined with knee joint mobilization for knee osteoarthritis : a randomized controlled trial
2017
Abstract: Objectives: This study aimed to first compare the effects of a preoperative treatment combining pain neuroscience education (PNE) with knee joint mobilization versus biomedical education with knee joint mobilization on central sensitization (CS) in patients with knee osteoarthritis, both before and after surgery. Second, we wanted to compare the effects of both interventions on knee pain, disability, and psychosocial variables. Materials and Methods: Forty-four patients with knee osteoarthritis were allocated to receive 4 sessions of either PNE combined with knee joint mobilization or biomedical education with knee joint mobilization before surgery. All participants completed self…
An easy and safe training method for trunk function improves mobility in total knee arthroplasty patients: A quasi-randomized controlled trial
2018
Objective Total knee arthroplasty (TKA) is aimed mainly at reducing pain and restoring mobility. However, mobility deficits can persist even longer than 1 year. The trunk function and movement velocity of any region have been recently recognized to be critical for determining mobility in older people. Therefore, the main goal of this quasi-randomized trial is to clarify the effectiveness of a novel training method, the seated side tapping (SST) training, for improving mobility by focusing on movement velocity of trunk function in the short term after TKA. Methods SST training consists of side trunk movements repeated as quickly as possible in a seated position. All participants after TKA we…
Impact of laparoscopy on oncological outcomes after colectomy for stage III colon cancer: A post-hoc multivariate analysis from PETACC8 European rand…
2021
Abstract Background In colon cancer (CC), surgery remains the mainstay of treatment with curative intent. Despite several clinical trials comparing open and laparoscopic approaches, data on long-term outcomes for stage III CC are lacking. Methods This post-hoc analysis of the European PETACC8 randomized phase 3 trial included patients from 340 sites between December 2005 and November 2009, with long follow-up (median 7.56 years). Patients were randomly assigned to FOLFOX or FOLFOX+cetuximab after colonic resection. The surgical approach was left to the referring surgeon's discretion. Results Among 2555 patients included, 1796 (70.29%) were operated on by open surgery and 759 (29.71%) by lap…