Early Feasibility Study to Evaluate the Safety and Effectiveness of the AccuraSee™ IOPCL for Secondary Implantation in the Capsular Bag to Improve Near and/or Intermediate Vision Following Previous Cataract Surgery
This is a study to evaluate the safety and effectiveness of the AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) to improve near and/or intermediate vision following previous cataract surgery.
‣ All ocular eligibility criteria refer to the study (non-dominant) eye only unless otherwise noted.
• Subjects aged 22 years and older.
• Subjects who have had cataract surgery with an Alcon monofocal intraocular lens model SN60WF, SA60WF, or SA60AT (with a lens power from 10.0D to 30.0D), or Johnson and Johnson monofocal lens model ZCB00 (with a lens power from 10.0D to 26.0D), or Zeiss monofocal lens model CT LUCIA 602 (with a lens power from 10.0D to 19.0D) clearly evidenced by photographic documentation with one of the following: patient medical record, clinic chart with labeling attached, surgical record with labeling attached, or patient identification card with make, model, power and serial number.
• Subjects who have had cataract surgery at least 6 months from the planned date of IOPCL surgery.
• Subjects who require a reading add of +1.50 to +2.50 to achieve an BCNVA of 20/32 or better.
• Subjects with uncorrected near visual acuity (UCNVA) 20/50 or worse.
• Subjects with best corrected distance visual acuity (BCDVA) 20/25 or better in both eyes.
• Subjects with uncorrected distance visual acuity (UCDVA) 20/25 or better in fellow eye.
• Subjects with best corrected near visual acuity (BCNVA) 20/32 or better.
• Subjects with a manifest refraction spherical equivalent (MRSE) in the study eye between +0.25D and +1.50D.
⁃ Subjects with \<1D of refractive cylinder determined by keratometry readings.
⁃ Subjects with a minimum endothelial cell count of 1800 cells/mm2.
⁃ Subjects with a tear break up time (TBUT) ≥ 7 seconds.
⁃ Subjects with a documented monovision tolerance, or who have successfully completed a 1-week contact lens trial prior to implantation with the IOPCL.
⁃ For subjects who are contact lens wearers, discontinuation of lens usage prior to the preoperative visit (at least 2 weeks for subjects using soft contact lenses and at least 3 weeks for hard or rigid gas permeable (RGP) lenses) except as required to test monovision acceptance.
⁃ For subjects who are contact lens wearers, two central keratometry readings with regular mires and two manifest refractions taken at least one week apart (keratometry values must not differ by more than ±0.50D in either principal meridian in the eye to be treated).
⁃ Subjects able to comprehend and sign a statement of informed consent.
⁃ Subjects willing and able to complete all required postoperative visits.
⁃ Subjects willing to abstain from pursuing any other refractive surgery for the duration of the study.