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Tests treatment safety and results for Refractive Surgery
Official title 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
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older. Healthy volunteers may be eligible.
You may be able to join if
- All ocular eligibility criteria refer to the study (non-dominant) eye only unless otherwise noted.
- people aged 22 years and older.
- people who have had cataract surgery with an Alcon monofocal intraocular lens model SN60WF, SA60WF, or SA60AT (with a lens power from 10.0D to...
- people who have had cataract surgery at least 6 months from the planned date of IOPCL surgery.
- people who require a reading add of +1.50 to +2.50 to achieve an BCNVA of 20/32 or better.
You likely can't join if
- people who have had cataract surgery with other than a monofocal posterior chamber intraocular lens (PCIOL).
- people who have had previous laser refractive surgery.
- people who have had cataract surgery with an Alcon monofocal intraocular lens model SN60WF, SA60WF, or SA60AT (with a lens power below 10.0D or...
- people who were treated with a PCIOL in a manner that is not consistent with the labeling, contraindications, or indications for use statement.
- people 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.
- people who have had a Nd:YAG capsulotomy less than 1 month prior to the planned date of the IOPCL surgery.
See the full eligibility criteria
Who can join
- All ocular eligibility criteria refer to the study (non-dominant) eye only unless otherwise noted.
- people aged 22 years and older.
- people 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...
- people who have had cataract surgery at least 6 months from the planned date of IOPCL surgery.
- people who require a reading add of +1.50 to +2.50 to achieve an BCNVA of 20/32 or better.
- people with uncorrected near visual acuity (UCNVA) 20/50 or worse.
- people with best corrected distance visual acuity (BCDVA) 20/25 or better in both eyes.
- people with uncorrected distance visual acuity (UCDVA) 20/25 or better in fellow eye.
- people with best corrected near visual acuity (BCNVA) 20/32 or better.
- people with a manifest refraction spherical equivalent (MRSE) in the study eye between +0.25D and +1.50D.
- people with \<1D of refractive cylinder determined by keratometry readings.
- people with a minimum endothelial cell count of 1800 cells/mm2.
- people with a tear break up time (TBUT) ≥ 7 seconds.
- people with a documented monovision tolerance, or who have successfully completed a 1-week contact lens trial prior to implantation with the IOPCL.
- For people who are contact lens wearers, discontinuation of lens usage prior to the preoperative visit (at least 2 weeks for people using soft contact lenses and at least 3 weeks for hard or rigid gas permeable (RGP)...
- For people 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...
- people able to comprehend and sign a statement of informed consent.
- people willing and able to complete all required postoperative visits.
- people willing to abstain from pursuing any other refractive surgery for the duration of the study.
What rules you out
- people who have had cataract surgery with other than a monofocal posterior chamber intraocular lens (PCIOL).
- people who have had previous laser refractive surgery.
- people 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...
- people who were treated with a PCIOL in a manner that is not consistent with the labeling, contraindications, or indications for use statement.
- people 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.
- people who have had a Nd:YAG capsulotomy less than 1 month prior to the planned date of the IOPCL surgery.
- people with a mesopic non-dilated pupil of greater than 5.5mm.
- people with a mesopic dilated pupil of less than 7.0 mm.
- people who have 1D or more of refractive cylinder determined by keratometry readings.
- people who had cataract surgery less than 6 months from the planned date of the IOPCL surgery.
- people whose PCIOL is substantially decentered (\> 1.0 mm).
- people 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...
- people with capsular instability.
- people with an anterior capsular defect.
- people with posterior capsular defect \< 0.5 mm from the edge of the existing IOL (caused by Nd:YAG capsulotomy).
- people with a tear or rent in the anterior or posterior capsule.
- people with any corneal pathology that is either progressive or sufficient to reduce BCDVA to 20/25 or worse.
- people 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...
- people with active moderate to severe meibomian gland dysfunction.
- people with clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy).
- people with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that would reduce BCDVA to 20/25 or worse.
- people with recurrent severe anterior or posterior segment inflammation of unknown etiology.
- people with microphthalmos.
- people with previous retinal detachment.
- people with diabetic retinopathy.
- people with iris neovascularization.
- people with a history of steroid-responsive rise in intraocular pressure (IOP), uncontrolled glaucoma or preoperative IOP \>21 mmHg.
- people with amblyopia in either eye.
- people who have current or historical significant binocular muscle imbalances or intermittent tropias and/or fail the cover test.
- people 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).
- people 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).
- people with a fundus not visible.
- people with aniridia.
- people with optic nerve atrophy.
- people with damaged or incomplete zonules.
- people 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).
- people with damage to the PCIOL.
- people with a known history of pseudoexfoliation, or pseudoexfoliation diagnosed at the preoperative visit or prior to IOPCL implantation.
- people 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.
- people 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...
- people participating in any other ophthalmic drug or device trial during the time of this investigation.
- people who are pregnant or nursing women; or women of child bearing age not using medically acceptable contraceptives.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.