A Prospective, Randomized, Subject- and Examiner-Masked, Multicenter Study Comparing Bilateral Cl… (NCT07693205) | Clinical Trial Compass
RecruitingPhase 4
A Prospective, Randomized, Subject- and Examiner-Masked, Multicenter Study Comparing Bilateral Clareon TruPlus and Bilateral Clareon Monofocal Intraocular Lens Implantation (Spherical and Toric) in Cataract Subjects
United States180 participantsStarted 2026-06-12
Plain-language summary
This investigator-initiated trial is a prospective, randomized, parallel-group, bilateral implantation study comparing Clareon TruPlus versus Clareon monofocal intraocular lenses (IOLs). Spherical and toric models are permitted in both arms based on standardized preoperative planning and clinical indication. Subjects and postoperative examiners/technicians will be masked to IOL assignment; surgeons will not be masked. The overall structure is modeled after randomized bilateral implantation cataract study designs with a Month 3 primary endpoint visit.
Who can participate
Age range
22 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
. Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts.
. Ability to understand and sign an IRB/ethics committee-approved informed consent form.
. Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures.
. Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
. Preoperative corneal astigmatism that can be corrected with a T3-T5 toric IOL, or with a spherical IOL plus LRIs/Aks, with either resulting in a predicted postoperative astigmatism \<0.50 D.
. IOL power and, if toric, cylinder availability within labeled ranges for the assigned IOL family.
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 photopic corrected distance visual acuity (CDVA) at 4 m
. Ability to understand and complete study questionnaires.
Exclusion criteria
. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation).
. Ocular conditions that could confound study results, including moderate-to-severe corneal pathology, irregular astigmatism, moderate-to-severe dry eye/ocular surface disease not optimized, preexisting retinal degenerative disease (e.g., age-related macular degeneration), diabetic retinopathy, or other clinically significant retinal pathology.
. Any form of confirmed glaucomatous optic neuropathy or other optic nerve disease expected to affect visual function outcomes.
. History of amblyopia, monofixation syndrome, or other binocular vision disorder with poor stereopsis that could confound binocular testing.
. Prior ocular surgery (including corneal refractive surgery) in either eye.
. Zonular laxity/dehiscence, pseudoexfoliation with clinically significant zonulopathy, nystagmus, or strabismus that could compromise uncomplicated surgery or reliable visual testing.
. Participation in another clinical study (interventional) that could interfere with study results.
. Planned monovision/mini-monovision or desire for monovision targeting.