180 Participants NeededMy employer runs this trial

Clareon Intraocular Lenses for Cataract

TH
Overseen ByTetiana Huff
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Berkeley Eye Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of intraocular lenses (IOLs) for individuals undergoing cataract surgery. The researchers aim to compare the Clareon TruPlus lens with the Clareon monofocal lens to determine which one better improves vision post-surgery. Participants must have cataracts in both eyes that significantly impair vision and be scheduled for cataract surgery. This study suits those interested in exploring new lens options that could enhance eyesight. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, providing participants an opportunity to benefit from well-established options.

What is the safety track record for these treatments?

Research has shown that Clareon TruPlus Monofocal Intraocular Lenses (IOLs) are safe for cataract surgery. Studies have found that patients tolerate these lenses well, and they improve vision by replacing the eye's cloudy lens, a common issue in cataracts. Notably, these lenses do not exhibit glistening (tiny water droplets inside the lens), enhancing their safety and effectiveness.

Additionally, Clareon monofocal IOLs, also included in this trial, have undergone long-term studies without major safety concerns. These studies demonstrate that the lenses remain clear and stable over time, providing good vision without significant side effects.

Both Clareon TruPlus and Clareon monofocal lenses have undergone extensive testing, and results suggest they are safe options for individuals undergoing cataract surgery.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Clareon Intraocular Lenses (IOLs) for cataracts because they offer advanced options over traditional lenses like acrylic or silicone-based IOLs. The Clareon TruPlus lens is particularly promising due to its enhanced optical clarity and reduced risk of photic phenomena, which can cause visual disturbances like halos or glares. Additionally, the Clareon monofocal lens provides improved visual outcomes with a focus on crisp distance vision. These features provide potential for better vision quality and a more comfortable post-surgery experience for patients.

What evidence suggests that this trial's treatments could be effective for cataract?

This trial will compare Clareon TruPlus intraocular lenses (IOLs) with Clareon monofocal lenses for people with cataracts. Studies have shown that Clareon IOLs provide excellent vision. Specifically, Clareon TruPlus IOLs, which participants in this trial may receive, improve vision by about 3.5 letters at certain distances compared to standard Clareon lenses. Long-term results indicate that these lenses offer stable and clear vision, with a low risk of cloudiness developing after surgery and no issues with tiny sparkling spots. Both Clareon TruPlus and standard lenses are effective and safe, providing good vision over time. These lenses replace the eye's natural lens damaged by cataracts, helping patients see more clearly.14567

Are You a Good Fit for This Trial?

This trial is for adults with cataracts in both eyes who are scheduled to have lens replacement surgery. Participants must be eligible for either spherical or toric intraocular lenses based on their eye measurements and overall health.

Inclusion Criteria

My vision after surgery is expected to be 20/25 or better in each eye.
IOL power and, if toric, cylinder availability within labeled ranges for the assigned IOL family
Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures
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Exclusion Criteria

I do not have mental or cognitive issues that would prevent me from following study instructions.
Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation)
I do not have serious eye conditions like severe dry eye, corneal issues, or retinal disease.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bilateral implantation of Clareon TruPlus or Clareon monofocal intraocular lenses

Surgery and immediate postoperative period

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary endpoint at Month 3

3 months
Primary endpoint visit at Month 3

What Are the Treatments Tested in This Trial?

Interventions

  • Clareon monofocal
  • Clareon TruPlus

Trial Overview

The study compares two types of artificial lenses used during cataract surgery: Clareon TruPlus and Clareon monofocal, including both standard (spherical) and astigmatism-correcting (toric) versions. Patients are randomly assigned to receive one type in both eyes.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Clareon TruPlusExperimental Treatment1 Intervention
Group II: Clareon monofocalActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Berkeley Eye Center

Lead Sponsor

Trials
5
Recruited
1,000+

Sengi

Industry Sponsor

Trials
28
Recruited
2,100+

Citations

Long-term real-life outcomes of the Clareon® hydrophobic ...

This real-life study reports high-performance and stable long-term refractive outcomes of the Clareon® IOL with good safety in terms of PCO and glistening.

Alcon Launches Clareon TruPlus, Enhanced Design ...

TruPlus demonstrates a 3.5 letter improvement in simulated visual acuity at -1.5 diopters (66 cm) compared to Clareon Monofocal 1,†

Clareon TruPlus IOLs for Cataracts

One study found that Clareon Monofocal IOLs, similar to the TruPlus version, were effective and safe over a year, with patients experiencing good vision and ...

Clareon® vs AcrySof® IQ Monofocal

Clareon® IOLs may have improved postoperative visual outcomes, achieving similar visual, refractive, and subjective outcomes.

Clareon TruPlus Study - ClinicalTrials.Veeva

The purpose of this research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs).

Study Details | NCT07502456 | Clareon TruPlus Study

The purpose of this research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs).

We are proud to announce the U.S. launch of Clareon® TruPlus, ...

Designed to increase depth of focus while maintaining the high-quality distance vision surgeons expect from a monofocal IOL*, TruPlus expands ...