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

Part of paid clinical trials in Sugar Land, Texas.

Sponsor
Berkeley Eye Center
Study ID
NCT07693205
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clareon TruPlus — DEVICE
    Bilateral implantation with Clareon TruPlus
  • Clareon monofocal — DEVICE
    Bilateral implantation with Clareon monofocal

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Clareon TruPlus
  • Active Comparator: Clareon monofocal

Primary Outcome Measure

Binocular photopic corrected distance visual acuity (CDVA) at 4 m [ Time Frame: 3 months postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Berkeley Eye Center - Sugar LandSugar LandTexas77478
Tetiana Clinical Research Coordinator
[email protected]
713-526-1600

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By research site
Berkeley Eye Center - Sugar Land· Sugar Land, TX

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