clinical evaluation of a 1-piece intraocular lens

Conditions: Cataract

Summary: the aims of this study are to: * demonstrate a reduction in postoperative cylinder compared to results from the control lens * demonstrate better uncorrected distance visual acuity compared to the control lens


Eligibility criteria:
inclusion criteria: * minimum 18 years of age * cataract for which phacoemulsification extraction and posterior chamber iol implantation has been planned for both eyes * preoperative best corrected distance visual acuity (bcdva)of 20/40 or worse (snellen), with or without glare, for each eye * bcdva projected to be better than 20/30 following cataract removal and iol implantation for each eye * preoperative keratometric cylinder of 0.75 diopters to 3.62 diopters for each eye (with exception of second eyes with 0.0-0.75 diopters planned to receive non-toric iol) * clear intraocular media other than cataract in both eyes * availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits * signed informed consent and hipaa authorization exclusion criteria: * requiring iols outside spherical power range of +15.0 to +28.0 diopters * dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)in either eye * previous corneal or intraocular surgery in either eye * irregular corneal astigmatism in either eye * corneal pathology/abnormality potentially affecting topography in either eye * corneal abnormalities such as stromal, epithelial or endothelial dystrophies in either eye * inability to achieve keratometric stability in either eye for contact lens wearers * subjects with diagnosed degenerative visual disorders in either eye(eg., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse * subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to iol decentration, including pseudoexfoliation, trauma, or posterior capsule defects * an eccentric anterior capsulorhexis, zonular damage/rupture or capsular tear/rupture during the cataract extraction procedure * use of systemic or ocular medications that may affect vision * prior, current, or anticipated use during the course of the nine month study of tamsulosin or silodosin (e.g., flomax, flomaxtra, rapaflo)likely to affect dilation or iris structure * poorly-controlled diabetes * acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.) * uncontrolled ocular hypertension or glaucomatous changes in the retina or visual field in either eye * known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.) * patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes * concurrent participation or participation during 30 days prior to preoperative visit in any other clinical trial

Keywords: cataract, intraocular lens