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.
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 who have had cataract surgery with other than a monofocal posterior chamber intraocular lens (PCIOL).
Subjects who have had previous laser refractive surgery.
Subjects who have had cataract surgery with an Alcon monofocal intraocular lens model SN60WF, SA60WF, or SA60AT (with a lens power below 10.0D or greater than 30.0D), or Johnson and Johnson monofocal intraocular lens model ZCB00 (with a lens power below 10.0D or greater than 26.0D) or Zeiss monofocal lens model CT LUCIA 602 (with a lens power below 10.0D or greater than 19.0D).
Subjects who were treated with a PCIOL in a manner that is not consistent with the labeling, contraindications, or indications for use statement.
Single group
Accurasee™ IOPCL
DeviceIntraocular pseudophakic capsular lens (IOPCL)
Improvement in uncorrected near visual acuity (UCNVA) at 40 cm/16 inches
Improvement in uncorrected near visual acuity (UCNVA) (at 40 cm/16 inches) at 12 months postoperatively. At least 75% of treated eyes should achieve an uncorrected near visual acuity (UCNVA) of 20/32 or better.
Improvement in uncorrected intermediate visual acuity (UCIVA) (at 66 cm/26 inches)
Improvement in uncorrected intermediate visual acuity (UCIVA) at 66 cm/26 inches at 12 months postoperatively. At least 75% of treated eyes should achieve a UCIVA of 20/40 or better.
Preservation of best corrected distance visual acuity (BCDVA)
Proportion of eyes (\< 5%) that lose two or more lines of best corrected distance visual acuity (BCDVA) (≥ 10 letters on the Early Treatment for Diabetic Retinopathy Study \[ETDRS\] chart).
Successful delivery of the intraocular pseudophakic capsular lens (IOPCL)
Successful delivery of the intraocular pseudophakic capsular lens (IOPCL) (defined as no capsular tear, no visible damage to either the posterior chamber intraocular lens \[PCIOL\] or the IOPCL, and adequate leaflet coverage of all IOPCL haptic tabs \[≥ 0.5 mm of anterior leaflet of capsule above where the haptics reside\]).
PCIOL Long-term adherence and positional stability (tilt)
Minimal tilt of the posterior chamber intraocular lens (PCIOL) confirmed via Anterion® AS-OCT (defined as ≤ 10 degrees between the postoperative tilt of the PCIOL and the pre-operative tilt of the PCIOL).
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