A Phase 4 interventional study of Clareon TruPlus and Clareon monofocal in Cataract, sponsored by Berkeley Eye Center. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Berkeley Eye Center · Phase 4, Interventional, and Basic science
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 180 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Berkeley Eye Center is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Clareon TruPlus
Device: Clareon monofocal
Bilateral implantation with Clareon TruPlus
Bilateral implantation with Clareon monofocal
Binocular photopic corrected distance visual acuity (CDVA) at 4 m
Time frame: 3 months postoperatively
Binocular photopic distance corrected intermediate visual acuity (DCIVA) at 66 cm
Time frame: 3 months postoperatively
Binocular photopic distance corrected near visual acuity (DCNVA) at 40 cm
Time frame: 3 months postoperatively
Binocular mesopic corrected distance visual acuity (CDVA) at 4 m
Time frame: 3 months postoperatively
Binocular photopic uncorrected distance visual acuity (UDVA) at 4 m
Time frame: 3 months postoperatively
Binocular photopic uncorrected intermediate visual acuity (UIVA) at 66 cm
Time frame: 3 months postoperatively
Binocular photopic uncorrected near visual acuity (UNVA) at 40 cm
Time frame: 3 months postoperatively
Monocular mesopic corrected distance visual acuity (CDVA) at 4 m
Time frame: 3 months postoperatively
Monocular mesopic distance corrected intermediate visual acuity (DCIVA) at 66 cm
Time frame: 3 months postoperatively
Binocular mesopic best corrected distance contrast sensitivity without glare
Time frame: 3 months postoperatively
Binocular mesopic best corrected distance contrast sensitivity with glare
Time frame: 3 months postoperatively
Photopic low-contrast (25%) BCDVA at 4 m without glare
Time frame: 3 months postoperatively
Binocular photopic distance-corrected defocus curve
Time frame: 3 months postoperatively
Monocular distance-corrected defocus curve (dominant eye)
Time frame: 3 months postoperatively
Visual disturbances questionnaire
Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.
Time frame: 3 months postoperatively
Satisfaction questionnaire
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.
Time frame: 3 months postoperatively
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jul 2027, 13 months after the start.
Of 39 non-industry phase 4 interventional studies under Cataract, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 13 months is below that.
Counting every sponsor, half of 46 studies reached it within 20 months; a quarter within 11 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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