RECRUITING

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

Conditions

Refractive Surgery Refractive Error - Myopia IOPCL Refractive error

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-23

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06625749

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 informed consent. 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.	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, contraindications, 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 steroid-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 contraceptives. 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.

Inclusion Criteria

Exclusion Criteria

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 informed consent.
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.

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, contraindications, 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 steroid-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 contraceptives.
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.

Contacts and Locations

Study Contact

Lynne Archer

CONTACT

714-651-6333

larcher@onpoint-vision.com

Tonya Porter

CONTACT

909-717-4493

tporter@onpoint-vision.com

Study Locations (Sites)

Midwest Vision Partners

Cleveland, Ohio, 44141

United States

Collaborators and Investigators

Sponsor: OnPoint Vision Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-23

Study Completion Date2026-03

Study Record Updates

Study Start Date2024-09-23

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

IOPCL
Refractive error

Additional Relevant MeSH Terms

Refractive Surgery
Refractive Error - Myopia