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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon TruPlus; Device: Clareon monofocal

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tetiana Huff; Phone Number: 713-620-7640; Email: tetiana.huff@berkeleyeye.com

Study Locations

• United States
  • Texas
    • Sugar Land, Texas, United States, 77478
      • Recruiting
      • Berkeley Eye Center - Sugar Land
      • Contact: Tetiana Clinical Research Coordinator; Phone Number: 713-526-1600; Email: tetiana.huff@berkeleyeye.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 as required by the protocol and complete all study testing procedures.
4. Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
5. 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.
6. IOL power and, if toric, cylinder availability within labeled ranges for the assigned IOL family.
7. Ability to understand and complete study questionnaires.

Exclusion Criteria:

1. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation).
2. 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.
3. Any form of confirmed glaucomatous optic neuropathy or other optic nerve disease expected to affect visual function outcomes.
4. History of amblyopia, monofixation syndrome, or other binocular vision disorder with poor stereopsis that could confound binocular testing.
5. Prior ocular surgery (including corneal refractive surgery) in either eye.
6. Zonular laxity/dehiscence, pseudoexfoliation with clinically significant zonulopathy, nystagmus, or strabismus that could compromise uncomplicated surgery or reliable visual testing.
7. Participation in another clinical study (interventional) that could interfere with study results.
8. Planned monovision/mini-monovision or desire for monovision targeting.
9. Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders) per investigator judgment.
10. Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide reliable self-assessments.
11. Any active ocular infection or inflammation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clareon TruPlus	Device: Clareon TruPlus; Bilateral implantation with Clareon TruPlus
Active Comparator: Clareon monofocal	Device: Clareon monofocal; Bilateral implantation with Clareon monofocal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular photopic corrected distance visual acuity (CDVA) at 4 m	3 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual disturbances questionnaire	Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.	3 months postoperatively
Satisfaction questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months postoperatively
Binocular photopic distance corrected intermediate visual acuity (DCIVA) at 66 cm		3 months postoperatively
Binocular photopic distance corrected near visual acuity (DCNVA) at 40 cm		3 months postoperatively
Binocular mesopic corrected distance visual acuity (CDVA) at 4 m		3 months postoperatively
Binocular photopic uncorrected distance visual acuity (UDVA) at 4 m		3 months postoperatively
Binocular photopic uncorrected intermediate visual acuity (UIVA) at 66 cm		3 months postoperatively
Binocular photopic uncorrected near visual acuity (UNVA) at 40 cm		3 months postoperatively
Monocular mesopic corrected distance visual acuity (CDVA) at 4 m		3 months postoperatively
Monocular mesopic distance corrected intermediate visual acuity (DCIVA) at 66 cm		3 months postoperatively
Binocular mesopic best corrected distance contrast sensitivity without glare		3 months postoperatively
Binocular mesopic best corrected distance contrast sensitivity with glare		3 months postoperatively
Photopic low-contrast (25%) BCDVA at 4 m without glare		3 months postoperatively
Binocular photopic distance-corrected defocus curve		3 months postoperatively
Monocular distance-corrected defocus curve (dominant eye)		3 months postoperatively

Collaborators and Investigators

• Sponsor: Berkeley Eye Center
• Collaborators: Sengi

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 102811821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes