Refractive SurgeryNCT06625749
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
A study testing Accurasee™ IOPCL in people with Refractive Surgery and Refractive Error - Myopia, run by OnPoint Vision Inc at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Surgery, Refractive Error - Myopia
- What is being tested?
- Accurasee™ IOPCL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subjects with iris neovascularization.
- Subjects with a history of steroid-responsive rise in intraocular pressure (IOP), uncontrolled glaucoma or preoperative IOP >21 mmHg.
- Subjects with amblyopia in either eye.
- Subjects who have current or historical significant binocular muscle imbalances or intermittent tropias and/or fail the cover test.
- 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).
- 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).
- Subjects with a fundus not visible.
- Subjects with aniridia.
- Subjects with optic nerve atrophy.
- Subjects with damaged or incomplete zonules.
- 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).
- Subjects with damage to the PCIOL.
- Subjects with a known history of pseudoexfoliation, or pseudoexfoliation diagnosed at the preoperative visit or prior to IOPCL implantation.
- 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.
- 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).
- Subjects participating in any other ophthalmic drug or device trial during the time of this investigation.
- Subjects who are pregnant or nursing women; or women of child bearing age not using medically acceptable contraceptives.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Midwest Vision Partners
Cleveland, Ohio, 44141
Julia Kantorik, COA, jkantorik@midwestvision.com
Erin Kus-Kreidler, COA, CCRC, ekus-kreidler@midwestvision.com
About this study
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
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.
- Conditions
- Refractive Surgery, Refractive Error - Myopia
- Being tested
- Accurasee™ IOPCL
- Keywords
- IOPCL, Refractive error
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accurasee™ IOPCLDevice
Intraocular pseudophakic capsular lens (IOPCL)
| Study group | Role | What they receive |
|---|---|---|
| AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) | Experimental | Not described Receives: Device: Accurasee™ IOPCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start23 Sep 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OnPoint Vision Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625749
- Sponsor's protocol ID
- CIIPCL-022R
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06625749
- Acronym / sponsor ID
- CIIPCL-022R
- Conditions
- Refractive Surgery, Refractive Error - Myopia
- Keywords
- IOPCL, Refractive error
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- OnPoint Vision IncIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) | Experimental | Device: Accurasee™ IOPCL |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (43 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accurasee™ IOPCLIntraocular pseudophakic capsular lens (IOPCL) | Device | AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) |
Primary outcome
Improvement in uncorrected near visual acuity (UCNVA) at 40 cm/16 inches
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accurasee™ IOPCL in people with Refractive Surgery and Refractive Error - Myopia, run by OnPoint Vision Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lynne Archer (714-651-6333, larcher@onpoint-vision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in uncorrected near visual acuity (UCNVA) at 40 cm/16 inches (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.