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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

ConditionCataract
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age22+
SponsorBerkeley Eye Center

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; surgeons will not be masked. The overall structure is modeled after randomized bilateral implantation cataract study designs with a Month 3 primary endpoint visit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clareon TruPlus

    Device

    Bilateral implantation with Clareon TruPlus

  • Clareon monofocal

    Device

    Bilateral implantation with Clareon monofocal

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Clareon TruPlusExperimental treatment 1 intervention
Group B: Clareon monofocalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Binocular photopic corrected distance visual acuity (CDVA) at 4 m

Time frame
3 months postoperatively

Secondary outcomes

Other outcomes

1

Binocular photopic distance corrected intermediate visual acuity (DCIVA) at 66 cm

Time frame
3 months postoperatively
2

Binocular photopic distance corrected near visual acuity (DCNVA) at 40 cm

Time frame
3 months postoperatively
3

Binocular mesopic corrected distance visual acuity (CDVA) at 4 m

Time frame
3 months postoperatively
4

Binocular photopic uncorrected distance visual acuity (UDVA) at 4 m

Time frame
3 months postoperatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Berkeley Eye Center

Lead sponsor

Sengi

Collaborator

Source ClinicalTrials.gov
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