Actively Recruiting
Early Feasibility Study to Evaluate the Safety and Effectiveness of the AccuraSee2 IOPCL for Secondary Implantation in the Capsular Bag to Improve Near and/or Intermediate Vision Following Previous Cataract Surgery
Led by OnPoint Vision Inc · Updated on 2024-10-03
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the AccuraSee2 intraocular pseudophakic capsular lens (IOPCL) for improving near and/or intermediate vision in people who have previously undergone cataract surgery. This study focuses on individuals who have had specific types of monofocal intraocular lenses implanted and are seeking better near vision through a myopic shift in the eye treated. The study is sponsored by OnPoint Vision Inc and aims to provide preliminary evidence regarding the device's performance. Participants will receive the AccuraSee2 IOPCL as a secondary implantation in the capsular bag. Eligible subjects must have had cataract surgery with certain monofocal lenses and meet specific vision requirements. The study includes a treatment period with the IOPCL implanted in the study eye. The primary measure of effectiveness is the improvement in uncorrected near visual acuity at 40 cm (16 inches) evaluated 12 months after implantation. During the study, participants will attend postoperative visits for evaluations and monitoring. Researchers will assess visual acuity changes, particularly near vision, along with safety parameters related to the lens implantation. Participants must be able to complete all required visits and agree to avoid other refractive surgeries during the trial. The total participation duration extends through at least 12 months post-implantation to observe outcomes and monitor safety.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 22 years and older.
- Previous cataract surgery with an Alcon monofocal intraocular lens model SN60WF, SA60WF, or SA60AT (lens power 10.0D to 30.0D), Johnson and Johnson model ZCB00 (lens power 10.0D to 26.0D), or Zeiss model CT LUCIA 602 (lens power 10.0D to 19.0D), documented by medical or surgical records.
- Cataract surgery at least 6 months before planned IOPCL implantation.
- Reading add required between +1.50 to +2.50 for best corrected near visual acuity of 20/32 or better.
- Uncorrected near visual acuity 20/50 or worse.
- Best corrected distance visual acuity 20/25 or better in both eyes.
- Uncorrected distance visual acuity 20/25 or better in the fellow eye.
- Best corrected near visual acuity 20/32 or better.
- Manifest refraction spherical equivalent in study eye between +0.25D and +1.50D.
- Less than 1 diopter of refractive cylinder by keratometry.
- Minimum endothelial cell count of 1800 cells/mm2.
- Tear break up time (TBUT) of 7 seconds or more.
- Documented monovision tolerance or successful 1-week contact lens trial.
- Discontinued contact lens use prior to preoperative visit as required.
- Two central keratometry readings and two manifest refractions within one week showing less than �b10.50D difference.
- Able to understand and sign informed consent.
- Willing and able to complete all postoperative visits.
- Willing to avoid other refractive surgeries during the study.
You will not qualify if you...
- Previous cataract surgery with lenses other than specified monofocal posterior chamber intraocular lenses.
- Previous laser refractive surgery.
- Cataract surgery with monofocal lenses outside specified power ranges.
- Inconsistent PCIOL treatment with labeling or indications.
- Continuous curvilinear capsulorhexis size less than 4.5 mm or more than 6.0 mm.
- Nd:YAG capsulotomy less than 1 month before IOPCL surgery.
- Mesopic pupil size outside 5.5 mm to 7.0 mm range.
- Refractive cylinder of 1 diopter or more.
- Cataract surgery less than 6 months before planned IOPCL surgery.
- Substantially decentered PCIOL greater than 1.0 mm.
- Anterior capsule fibrosis or phimosis affecting outcomes or increasing risk.
- Capsular instability or defects in anterior or posterior capsule.
- Corneal pathology or abnormalities affecting vision or assessment.
- Moderate to severe meibomian gland dysfunction.
- Severe corneal dystrophy.
- Degenerative visual disorders reducing best corrected visual acuity.
- Severe recurrent inflammation of unknown cause.
- Microphthalmos or previous retinal detachment.
- Diabetic retinopathy or iris neovascularization.
- History of steroid-responsive intraocular pressure rise, uncontrolled glaucoma, or high preoperative IOP.
- Amblyopia or significant binocular muscle imbalances.
- Failure in binocular function tests.
- Fundus not visible.
- Aniridia or optic nerve atrophy.
- Damaged or incomplete zonules or PCIOL.
- Pseudoexfoliation diagnosis.
- Acute, chronic, or uncontrolled systemic or ocular disease increasing risk.
- Use of medications like tamsulosin or similar affecting iris behavior.
- Participation in other ophthalmic drug or device trials.
- Pregnancy, nursing, or women not using acceptable contraception.
- Occupational or environmental visual demands increasing postoperative risk.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure with immediate post-operative period
Participants receive the AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) implanted in the capsular bag following previous cataract surgery.
1 implantation visit (in-person) and approximately 6 post-operative visits
Duration - Up to 12 months
Participants are monitored for safety and effectiveness outcomes after the implantation of the AccuraSee™ IOPCL.
Regular follow-up visits during 12 months
Trial Site Locations
Total: 1 location
1
Midwest Vision Partners
Cleveland, Ohio, United States, 44141
Actively Recruiting
Research Team
L
Lynne Archer
T
Tonya Porter
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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