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

Recruiting now · Not applicable

Conditions studied: Refractive Surgery, Refractive Error - Myopia

In brief

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.

Key facts

Study ID

NCT06625749

Run by

OnPoint Vision Inc

People needed

10

Starts

2024-09-23

Expected to finish

2026-03-01

Last updated by the study team

2024-10-03

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

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.
• 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.

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).
• Subjects with a tear or rent in the anterior or posterior capsule.
• Subjects with any corneal pathology that is either progressive or sufficient to reduce BCDVA to 20/25 or worse.
• Subjects with any corneal abnormality, other than regular corneal astigmatism, that prevents accurate assessment of fluorescein tear break up time or, in the opinion of the investigator, would confound the outcome(s) of the study.
• Subjects with active moderate to severe meibomian gland dysfunction.
• Subjects with clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy).
• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that would reduce BCDVA to 20/25 or worse.
• Subjects with recurrent severe anterior or posterior segment inflammation of unknown etiology.
• Subjects with microphthalmos.
• Subjects with previous retinal detachment.
• Subjects with diabetic retinopathy.

Where it is running

• Midwest Vision Partners — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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