Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy (NCT06041139) | Clinical Trial Compass
CompletedNot Applicable
Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
United States230 participantsStarted 2022-09-12
Plain-language 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-sponsored post marketing study done outside of the US claim superiority of range of vision for the Tecnis Synergy IOL over the PanOptix IOL.
Hypothesis:
* Patients with bilateral Panoptix IOLs have non-inferior distance, intermediate, and near visual acuity compared to patients with bilateral Synergy IOLs in both photopic and mesopic conditions with less glare, haloes, and/or starbursts.
Unmet Medical Need:
* There is a need to look at patient visual outcomes and the visual disturbance profile comparing trifocal technology with combined EDOF/Bifocal technology in the United States.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm