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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorOnPoint Vision Inc

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Accurasee™ IOPCL

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators