Refractive Errors Clinical Trial
Official title:
Early Feasibility Study to Evaluate the Safety and Effectiveness of the AccuraSee for Secondary Implantation in the Capsular Bag to Correct Residual Refractive Errors of Previous Cataract Surgery
To determine if the intraocular pseudophakic contact lens (IOPCL), referred to as the AccuraSee, corrects residual refractive errors after cataract surgery using a plus powered lens in subjects with ocular pathology previously implanted with a Bausch and Lomb LI61AO or LI61SE monofocal posterior chamber intraocular lens (PCIOL) and to confirm its positional stability and adherence relative to the PCIOL.
This will be a 12-month study in which a maximum of 10 pseudophakic patients from three clinical sites will be enrolled. All enrolled subjects will receive an AccuraSee IOPCL with +3.0D add to correct residual refractive errors identified after cataract surgery. The primary objective of this study is to determine the stability of the AccuraSee IOPCL to successfully adhere to a pseudophakic intraocular lens (PCIOL) without rotation or slippage. The secondary objective of this study is to determine if the AccuraSee IOPCL can successfully correct refractive errors in subjects previously implanted with a Bausch and Lomb LI61AO and LI61SE monofocal intraocular lens. ;
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