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
Recruiting
Phase 4
Interventional Study
Cataract
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 180 (estimated)
- Sponsor
- Berkeley Eye Center · Other
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About This Trial
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; surgeon…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts.
2. Ability to understand and sign an IRB/ethics committee-approved informed consent form.
3. Willingness and ability to attend all scheduled study visits …
Contacts