Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clar… (NCT07589894) | Clinical Trial Compass
By InvitationNot Applicable
Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus Intraocular Lens (IOL)
United States50 participantsStarted 2026-05
Plain-language summary
This study aims to generate data that characterizes visual outcomes, including the binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm or defocus behavior, of the Clareon TruPlus modified monofocal intraocular lens (IOL).
Clareon TruPlus IOL is designed to provide an extended range of vision compared to the parent monofocal IOL. Clareon TruPlus IOL delivers excellent intermediate vision without compromising distance vision including the quality of vision with low incidence of visual disturbances in normal cataract patients.
Binocular distance-corrected intermediate visual acuity at 66cm will be assessed at a pre-specified postoperative interval 12 weeks after second eye surgery. This study hypothesizes that Clareon TruPlus IOL delivers good binocular DCIVA at 66cm 12 weeks after second eye surgery.
Who can participate
Age range
50 Years – 80 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:
* Able and willing to understand and sign informed consent.
* Able and willing to complete all required study visits.
* Diagnosed with age-related cataracts in both eyes (OU)
* Bilateral age-related cataract scheduled for phacoemulsification in both eyes by a single surgeon.
* Surgeon predicts postoperative best corrected distance visual acuity (BCDVA) of ≥ 20/25 or better with Manifest Refractive Spherical Equivalent (MRSE) ±0.50 D of plano and in each eye post-operatively.
* Clear intraocular media aside from cataract.
* Will receive TruPlus bilaterally
* Postoperative residual astigmatism ≤ 0.75 D in both eyes.
* Refractive target: Emmetropia OU
* Patient groups agreeing to either Femtosecond Laser Assisted Cataract Surgery (FLACS) or Standard phaco
Exclusion Criteria:
* Ocular comorbidities affecting visual outcomes, including but not limited to:
* Macular disease (e.g., Age-Related Macular Degeneration \[AMD\], Diabetic Macular Edema \[DME\], Epiretinal Membrane \[ERM\]).
* Active ocular inflammation.
* Any investigator-determined condition likely to confound postoperative visual performance.
* Strabismus with or without amblyopia in either eye.
* Prior anterior or posterior segment surgery, including corneal refractive procedures.
* History of retinal detachment.
* Degenerative retinal or visual disorders deemed clinically significant by the investigator.
* Diagnosed glaucoma (of any stage, if deemed vision-impacting by investigator).
* Systemic c…
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 distance-corrected intermediate visual acuity (DCIVA) and Logarithm of the Minimum Angle of Resolution (logMAR) at 66cm at 12 weeks after second eye surgery
Timeframe: Baseline and 12 weeks after second eye surgery