Status:
COMPLETED
Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
Lead Sponsor:
Berkeley Eye Center
Conditions:
Pseudophakia
Eligibility:
All Genders
40+ years
Brief Summary
Background: * The Tecnis Synergy intraocular lens (IOL) has a claim to allow patients to experience continuous high-contrast vision from far through near even in low-light conditions. * A J\&J-sponso...
Detailed Description
* This is a non-interventional single center, two-arm comparative study of the outcomes for patients following successful, uncomplicated cataract surgery. * There will be 155 subjects enrolled in each...
Eligibility Criteria
Inclusion
- Are willing and able to understand and sign an informed consent
- Are willing and able to complete all required study visits
- Are more than 40 years of age
- Patient diagnosed with cataracts both eyes and underwent uncomplicated cataract surgeries
- Patients with bilateral PanOptix (toric or non-toric)
- Patients with bilateral Synergy (toric or non-toric)
- Post-op best Corrected distance Visual Acuity for each eye is logMAR 0.1 (20/25) or better after cataract removal.
- Post-op residual refractive error +0.50 - -0.50 SE with ≤ 0.75 residual refractive astigmatism in each eye
- Minimum of two weeks post Yttrium Aluminum Garnet capsulotomy to treat posterior capsular opacification
Exclusion
- Corneal dystrophies or degenerations
- Failure to return for follow up at designed intervals.
- Any conditions that might affect cataract removal (pseudoexfoliation, posterior polar cataract, Flomax, etc.)
- Any conditions during surgery that might prolong the cataract removal (capsular tear, inadequate pupil dilation, etc.)
- Strabismus with or without amblyopia in either eye
- Previous ocular surgery of any kind
- History of retinal detachment
- Any corneal abnormality, other than regular corneal astigmatism (as determined by corneal topography) that in the opinion of the investigator would confound the outcome(s) of the study
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that in the opinion of the investigator is clinically significant
- Subjects with glaucoma
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, etc)
Key Trial Info
Start Date :
September 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 16 2024
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT06041139
Start Date
September 12 2022
End Date
April 16 2024
Last Update
May 23 2025
Active Locations (1)
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1
Berkeley Eye Center
Houston, Texas, United States, 77027