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

NCT06625749 | Recruiting FDA Device

• 1 other identifier: CIIPCL-022R
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractive Surgery; Refractive Error - Myopia

Keywords

IOPCL; Refractive error

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Other Outcomes (9)

• Improvement in uncorrected intermediate visual acuity (UCIVA) (at 66 cm/26 inches)

  12 months

• Preservation of best corrected distance visual acuity (BCDVA)

  12 Months

• Successful delivery of the intraocular pseudophakic capsular lens (IOPCL)

  Postoperatively from 7-14 days visit through 12 months visit

Study Arms (1)

AccuraSee™ intraocular pseudophakic capsular lens (IOPCL)

EXPERIMENTAL

Device: Accurasee™ IOPCL

Interventions

Accurasee™ IOPCL DEVICE

Intraocular pseudophakic capsular lens (IOPCL)

AccuraSee™ intraocular pseudophakic capsular lens (IOPCL)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects whose continuous curvilinear capsulorhexis is less than 4.5 mm or more than 6.0 mm in size at the time of the preoperative visit.
• Subjects who have had a Nd:YAG capsulotomy less than 1 month prior to the planned date of the IOPCL surgery.
• Subjects with a mesopic non-dilated pupil of greater than 5.5mm.
• Subjects with a mesopic dilated pupil of less than 7.0 mm.
• Subjects who have 1D or more of refractive cylinder determined by keratometry readings.
• Subjects who had cataract surgery less than 6 months from the planned date of the IOPCL surgery.
• Subjects whose PCIOL is substantially decentered (\> 1.0 mm).
• Subjects with anterior capsule fibrosis and phimosis that, in the opinion of the investigator, may confound the outcome or increase the risk to the subject (e.g., excessive capsule contraction potentially obstructing the visual axis or causing late secondary complications to the PCIOL such as pseudophacodenesis and IOL tilt, decentration, or dislocation due to zonular laxity, weakness or dehiscence).
• Subjects with capsular instability.
• Subjects with an anterior capsular defect.
• Subjects with posterior capsular defect \< 0.5 mm from the edge of the existing IOL (caused by Nd:YAG capsulotomy).

Sponsors & Collaborators

• OnPoint Vision Inc: lead

Study Sites (1)

Midwest Vision Partners

Cleveland, Ohio, 44141, United States

RECRUITING

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Lynne Archer

CONTACT

714-651-6333; larcher@onpoint-vision.com

Tonya Porter

CONTACT

909-717-4493; tporter@onpoint-vision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 3, 2024
• Study Start: September 23, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)