ClinicalTrials.gg
RecruitingNCT06625749Updated Oct 3, 2024

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

An interventional study of Accurasee™ IOPCL in Refractive Surgery and Refractive Error - Myopia, sponsored by OnPoint Vision Inc. Recruiting at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by OnPoint Vision Inc · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Refractive Surgery
  • Refractive Error - Myopia

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Keywords

  • IOPCL
  • Refractive error
03

In context

Refractive Errors

420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.

This study's planned enrollment of 10 is below the median of 76 across 301 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

OnPoint Vision Inc is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 with labeling attached, surgical record with labeling attached, or patient identification card with make, model, power and serial number.
  3. Subjects who have had cataract surgery at least 6 months from the planned date of IOPCL surgery.
  4. Subjects who require a reading add of +1.50 to +2.50 to achieve an BCNVA of 20/32 or better.
  5. Subjects with uncorrected near visual acuity (UCNVA) 20/50 or worse.
  6. Subjects with best corrected distance visual acuity (BCDVA) 20/25 or better in both eyes.
  7. Subjects with uncorrected distance visual acuity (UCDVA) 20/25 or better in fellow eye.
  8. Subjects with best corrected near visual acuity (BCNVA) 20/32 or better.
  9. Subjects with a manifest refraction spherical equivalent (MRSE) in the study eye between +0.25D and +1.50D.
  10. Subjects with \<1D of refractive cylinder determined by keratometry readings.
  11. Subjects with a minimum endothelial cell count of 1800 cells/mm2.
  12. Subjects with a tear break up time (TBUT) ≥ 7 seconds.
  13. Subjects with a documented monovision tolerance, or who have successfully completed a 1-week contact lens trial prior to implantation with the IOPCL.
  14. 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.
  15. 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).
  16. Subjects able to comprehend and sign a statement of .
  17. Subjects willing and able to complete all required postoperative visits.
  18. Subjects willing to abstain from pursuing any other refractive surgery for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have had cataract surgery with other than a monofocal posterior chamber intraocular lens (PCIOL).
  2. Subjects who have had previous laser refractive surgery.
  3. 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).
  4. Subjects who were treated with a PCIOL in a manner that is not consistent with the labeling, , or indications for use statement.
  5. 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.
  6. Subjects who have had a Nd:YAG capsulotomy less than 1 month prior to the planned date of the IOPCL surgery.
  7. Subjects with a mesopic non-dilated pupil of greater than 5.5mm.
  8. Subjects with a mesopic dilated pupil of less than 7.0 mm.
  9. Subjects who have 1D or more of refractive cylinder determined by keratometry readings.
  10. Subjects who had cataract surgery less than 6 months from the planned date of the IOPCL surgery.
  11. Subjects whose PCIOL is substantially decentered (> 1.0 mm).
  12. 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).
  13. Subjects with capsular instability.
  14. Subjects with an anterior capsular defect.
  15. Subjects with posterior capsular defect \< 0.5 mm from the edge of the existing IOL (caused by Nd:YAG capsulotomy).
  16. Subjects with a tear or rent in the anterior or posterior capsule.
  17. Subjects with any corneal pathology that is either progressive or sufficient to reduce BCDVA to 20/25 or worse.
  18. 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.
  19. Subjects with active moderate to severe meibomian gland dysfunction.
  20. Subjects with clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy).
  21. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that would reduce BCDVA to 20/25 or worse.
  22. Subjects with recurrent severe anterior or posterior segment inflammation of unknown etiology.
  23. Subjects with microphthalmos.
  24. Subjects with previous retinal detachment.
  25. Subjects with diabetic retinopathy.
  26. Subjects with iris neovascularization.
  27. Subjects with a history of -responsive rise in intraocular pressure (IOP), uncontrolled glaucoma or preoperative IOP >21 mmHg.
  28. Subjects with amblyopia in either eye.
  29. Subjects who have current or historical significant binocular muscle imbalances or intermittent tropias and/or fail the cover test.
  30. Subjects who fail to demonstrate normal perception at near (33 cm) on the Worth 4 Dot Binocular Test for binocular function (using best corrected visual acuity).
  31. Subjects who fail to demonstrate at least gross stereopsis (i.e., pinching fly's wings in front of test booklet) with best corrected visual acuity on the Titmus Stereo Test (at near).
  32. Subjects with a fundus not visible.
  33. Subjects with aniridia.
  34. Subjects with optic nerve atrophy.
  35. Subjects with damaged or incomplete zonules.
  36. Subjects with inadequate anterior leaflet coverage of the PCIOL (defined as less than 0.5 mm of anterior leaflet of capsule above where the haptics will reside).
  37. Subjects with damage to the PCIOL.
  38. Subjects with a known history of pseudoexfoliation, or pseudoexfoliation diagnosed at the preoperative visit or prior to IOPCL implantation.
  39. Subjects with acute, chronic or uncontrolled systemic or ocular disease that in the opinion of the investigator would increase the operative risk or confound the outcome(s) of the study.
  40. Subjects taking medications that, in the opinion of the investigator, may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax)) or taking other medications with similar side effects (floppy iris syndrome).
  41. Subjects participating in any other ophthalmic drug or device trial during the time of this investigation.
  42. Subjects who are pregnant or nursing women; or women of child bearing age not using medically acceptable .
  43. Subjects with certain occupational and environmental visual demands (i.e. piloting an airplane, working on and operating dangerous machinery) in the opinion of the investigator would increase the post-operative risk.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    AccuraSee™ intraocular pseudophakic capsular lens (IOPCL)

    Device: Accurasee™ IOPCL

Interventions

  • DeviceAccurasee™ IOPCL

    Intraocular pseudophakic capsular lens (IOPCL)

06

What researchers measure

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.

    Time frame: 12 months

Other outcomes

  1. 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.

    Time frame: 12 months

  2. 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).

    Time frame: 12 Months

  3. 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 \[≥ 0.5 mm of anterior leaflet of capsule above where the haptics reside\]).

    Time frame: Postoperatively from 7-14 days visit through 12 months visit

  4. 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).

    Time frame: Postoperatively from 30-60 days visit through 12 months visit

  5. Intraocular Pseudophakic Capsular Lens (IOPCL) Long-term adherence and positional stability (tilt)

    Minimal tilt of the intraocular pseudophakic capsular lens (IOPCL) (using the posterior chamber intraocular lens \[PCIOL\] as a reference point) confirmed via Anterion® AS-OCT (defined as ≤ 10 degrees between the post-operative tilt of the PCIOL and the postoperative tilt of the IOPCL).

    Time frame: Postoperatively from 30-60 days visit through 12 months visit

  6. PCIOL/IOPCL Complex Long-term adherence and positional stability (decentration)

    Decentration of the posterior chamber intraocular lens/intraocular pseudophakic capsular lens (PCIOL/IOPCL complex) (defined as uniform exposed area of the PCIOL outside of the IOPCL at the vertical and horizontal meridians between ≥ 0.5 mm and ≤ 1.0 mm.

    Time frame: Postoperatively starting at 7-14 days through 12 months

  7. Intraoperative and postoperative adverse events

    Characterization and incidence of cumulative and persistent intraoperative and post-operative adverse events.

    Time frame: Intraoperative and Postoperative through 12 months

  8. Secondary Surgical Interventions (SSIs)

    Incidence of secondary surgical interventions (SSIs) (e.g., removal of interlenticular opacity, repositioning of intraocular pseudophakic capsular lens \[IOPCL\], explant of IOPCL, repositioning of posterior chamber intraocular lens \[PCIOL\]) (excluding neodymium-doped yttrium aluminum garnet \[Nd:YAG\] treatments for posterior capsule opacification (PCO).

    Time frame: Postoperative through 12 months

  9. Endothelial Cell Counts

    Endothelial Cell Counts (mean loss, minimum, maximum, and quartiles of endothelial cell density \[ECD\] loss) * Percent of eyes that lose 20% or more ECD * Percent of eyes that lose 25% or more ECD * Percent of eyes that lose 30% or more ECD

    Time frame: Postoperatively beginning with 120-180 days through 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06625749
Lead sponsor
OnPoint Vision Inc
Responsible party
Sponsor
First posted
Oct 3, 2024
Start date
Sep 23, 2024
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Oct 3, 2024

Study contacts

Lynne Archer
Contact
larcher@onpoint-vision.com
714-651-6333
Tonya Porter
Contact
tporter@onpoint-vision.com
909-717-4493

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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