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
OnPoint Vision Inc
Summary
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.
Description
The objective of this study is to provide preliminary evidence of the safety and efficacy of the AccuraSee intraocular pseudophakic capsular lens (IOPCL) in qualified subjects previously implanted with an Alcon monofocal intraocular lens model SN60WF, SA60WF, or SA60AT, Johnson and Johnson model ZCB00, or Zeiss model CT LUCIA 602 who desire near vision of 20/32 or better via a myopic shift in the eye to be treated.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: All ocular eligibility criteria refer to the study (non-dominant) eye only unless otherwise noted. 1. Subjects aged 22 years and older. 2. 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…
Interventions
- DeviceAccurasee™ IOPCL
Intraocular pseudophakic capsular lens (IOPCL)
Location
- Midwest Vision PartnersCleveland, Ohio