Actively Recruiting
Phase Not Applicable
Age: 22Years +
All Genders
Healthy Volunteers
NCT06625749
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
Led by OnPoint Vision Inc · Updated on 2024-10-03
10
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Age: 22Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 22 years and older
- Prior cataract surgery with Alcon monofocal lens model SN60WF, SA60WF, or SA60AT (lens power 10.0D to 30.0D), Johnson and Johnson model ZCB00 (10.0D to 26.0D), or Zeiss model CT LUCIA 602 (10.0D to 19.0D), confirmed by documentation
- Cataract surgery performed at least 6 months before planned IOPCL implantation
- Require a reading addition of +1.50 to +2.50 to achieve best corrected near visual acuity (BCNVA) of 20/32 or better
- Uncorrected near visual acuity (UCNVA) of 20/50 or worse
- Best corrected distance visual acuity (BCDVA) of 20/25 or better in both eyes
- Uncorrected distance visual acuity (UCDVA) of 20/25 or better in the fellow eye
- Best corrected near visual acuity (BCNVA) of 20/32 or better
- Manifest refraction spherical equivalent (MRSE) in study eye between +0.25D and +1.50D
- Less than 1D 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 before implantation
- Contact lens wearers must discontinue lens use before preoperative visit (2 weeks for soft lenses, 3 weeks for hard or RGP lenses) except for monovision testing
- Two central keratometry readings and two manifest refractions at least one week apart with less than �b10.50D variation
- Able to understand and sign informed consent
- Willing and able to complete all postoperative visits
- Willing to avoid other refractive surgery during the study
You will not qualify if you...
- Prior cataract surgery with any intraocular lens other than specified monofocal posterior chamber intraocular lenses
- Previous laser refractive surgery
- Cataract surgery with specified lenses outside defined power ranges
- Inconsistent PCIOL treatment with labeling or indications
- Capsulorhexis size less than 4.5 mm or greater than 6.0 mm
- Nd:YAG capsulotomy less than 1 month before planned IOPCL surgery
- Mesopic non-dilated pupil larger than 5.5 mm or mesopic dilated pupil smaller than 7.0 mm
- Refractive cylinder of 1D or more by keratometry
- Cataract surgery less than 6 months before planned IOPCL surgery
- Substantially decentered PCIOL (>1.0 mm)
- Anterior capsule fibrosis or phimosis that may affect outcomes or increase risk
- Capsular instability or anterior capsular defect
- Posterior capsular defect less than 0.5 mm from IOL edge
- Tear or rent in anterior or posterior capsule
- Progressive or vision-reducing corneal pathology
- Corneal abnormalities interfering with tear break up time assessment
- Moderate to severe meibomian gland dysfunction
- Severe corneal dystrophy
- Degenerative visual disorders reducing BCDVA to 20/25 or worse
- Recurrent severe anterior or posterior segment inflammation of unknown cause
- Microphthalmos
- Previous retinal detachment
- Diabetic retinopathy
- Iris neovascularization
- History of steroid-responsive IOP rise, uncontrolled glaucoma, or preoperative IOP >21 mmHg
- Amblyopia in either eye
- Significant binocular muscle imbalances, intermittent tropias, or cover test failure
- Failure of normal near perception on Worth 4 Dot Binocular Test
- Failure of gross stereopsis on Titmus Stereo Test
- Non-visible fundus
- Aniridia
- Optic nerve atrophy
- Damaged or incomplete zonules
- Inadequate anterior leaflet coverage of PCIOL
- PCIOL damage
- History or diagnosis of pseudoexfoliation
- Acute, chronic, or uncontrolled systemic or ocular disease increasing risk or confounding outcomes
- Use of medications that may increase risk or confound outcomes (e.g., tamsulosin hydrochloride or similar)
- Participation in other ophthalmic drug or device trials during this study
- Pregnancy, nursing, or women of childbearing potential not using acceptable contraception
- Occupational or environmental visual demands increasing postoperative risk (e.g., piloting, operating dangerous machinery)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
Midwest Vision Partners
Cleveland, Ohio, United States, 44141
Actively Recruiting
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Research Team
L
Lynne Archer
CONTACT
T
Tonya Porter
CONTACT
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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