COMPARATIVE CLINICAL-TRIAL OF AMO VITRAX AND HEALON USE IN EXTRACAPSULAR CATARACT-EXTRACTION

This randomized, single-masked, multicenter clinical trial, comprising 95 patients enrolled at five sites, evaluated the performance of AMO( R) Vitrax(R) and Healon(R) viscoelastic materials during cataract surg ery, Patients were examined preoperatively and at one day, four days, one month, and three months postoperatively. The following measurement s were recorded and analyzed: percentage of endothelial cell loss from preoperative to three months postoperative; change in intraocular pre ssure (IOP) from preoperative to 24 hours postoperatively; postoperati ve corrected visual acuity; subjective assessment of ability of viscoe lastic to create and maintain tissue space; intraocular transparency; ease of evacuation. Three months postoperatively, endothelial cell los s was 4.9% (+/-8.3%) for the AMO Vitrax group and 6.3% (+/-10.5%) for the Healon group. One day postoperatively, IOP decreased by 1.6 mm Hg and increased by +1.1 mm Hg, respectively. Postoperative visual acuiti es were similar between the two groups at three months. Subjective ass essment of transparency was higher for Healon. Assessment of tissue sp ace maintenance was similar between the two materials. Healon was rate d as slightly easier to evacuate.