Clareon TruPlus IOLs for Cataracts
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new lenses for individuals with cataracts, which are cloudy spots in the eye that affect vision. The trial evaluates the safety and effectiveness of Clareon TruPlus lenses when replacing cloudy lenses during cataract surgery. Two types of lenses are under examination: Clareon TruPlus Monofocal Non-Toric IOL for regular vision correction and Clareon TruPlus Monofocal Toric IOL for correcting astigmatism, a condition where the eye is shaped more like a football than a basketball, causing blurry vision. Individuals with cataracts in both eyes who require surgery in both may be suitable candidates. However, those with other serious eye conditions, such as glaucoma or severe dry eye, are not eligible. As an unphased trial, this study offers an opportunity to contribute to advancing cataract treatment options.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that Clareon TruPlus IOLs are safe for cataract patients?
Research has shown that Clareon TruPlus Monofocal Intraocular Lenses (IOLs) are safe, as indicated by previous studies. These lenses replace the eye's cloudy lens during cataract surgery. 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 stable lenses in the eye.
Clareon TruPlus IOLs aim to improve focus while maintaining clear distance vision, enhancing vision without compromising safety. Although new, these lenses are based on the Clareon Monofocal IOLs, already recognized for their safety.
Overall, Clareon TruPlus IOLs are expected to be well-tolerated, with few side effects reported in similar lenses. This suggests they should be a safe choice for individuals seeking improved vision after cataract surgery.12345Why are researchers excited about this trial?
The Clareon TruPlus IOLs are unique because they use advanced optics in both monofocal and toric versions to improve vision clarity for cataract patients. Unlike traditional intraocular lenses, these IOLs are made from a new material that reduces glare and halos, which can significantly enhance night vision. Moreover, the toric version offers precise astigmatism correction, potentially reducing the need for glasses post-surgery. Researchers are excited because these features could lead to better overall visual outcomes and increased patient satisfaction compared to standard IOLs.
What evidence suggests that Clareon TruPlus IOLs are effective for cataracts?
Research has shown that Clareon TruPlus Monofocal Intraocular Lenses (IOLs) improve vision after cataract surgery. This trial will evaluate both the Clareon TruPlus Monofocal Non-Toric IOL and the Clareon TruPlus Monofocal Toric IOL. Studies have found that these lenses provide excellent vision for distance and arm's length viewing. Specifically, the TruPlus IOLs enhance visual clarity by about 3.5 letters on an eye chart compared to older models. Patients typically experience minimal lens movement after placement, maintaining stable and clear vision. Additionally, over 99% of patients achieve good vision, enabling clear sight for reading and everyday activities.23467
Who Is on the Research Team?
Clinical Trial Lead, Surgical
Principal Investigator
Alcon Research, LLC
Are You a Good Fit for This Trial?
This trial is for people with cataracts in both eyes who are scheduled for standard cataract surgery and have astigmatism that can be corrected with the study lenses. Participants should be expected to achieve good vision after surgery, based on their doctor's assessment.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative
Participants attend a preoperative visit to prepare for cataract surgery
Surgical
Participants undergo cataract surgery for implantation of Clareon TruPlus Monofocal IOLs
Postoperative
Participants attend postoperative visits to monitor the safety and performance of the IOLs
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Clareon TruPlus Monofocal Non-Toric IOL
- Clareon TruPlus Monofocal Toric IOL
Trial Overview
The study is testing two types of Clareon TruPlus intraocular lenses (IOLs)—a regular monofocal lens and a toric version designed to correct astigmatism—implanted during cataract surgery using phacoemulsification.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Implantation with the Clareon TruPlus Monofocal IOL (Non-Toric or Toric) following removal of the clouded natural lens using phacoemulsification
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alcon Research
Lead Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
David Endicott
Alcon Research
Chief Executive Officer since 2018
MBA from University of Southern California
Citations
Real-World Visual Outcomes and Rotational Stability of ... - PMC
Clareon monofocal toric IOLs provided excellent distance and functional intermediate visual acuities, minimal rotation following implantation, ...
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,†; TruPlus ...
3.
myalcon.com
myalcon.com/international/professional/cataract-surgery/iols/clareon-monofocal-and-toric/Clareon® Monofocal IOL and Monofocal Toric IOL | Alcon ...
Clareon® Monofocal IOLs give your patients functional intermediate vision while maintaining exceptional sharp, crisp distance vision.
Clareon TruPlus IOLs for Cataracts · Info for Participants
The purpose of this research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs).
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).
NCT07502456 | Clareon TruPlus Study
The purpose of this research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs). IOLs are medical ...
7.
finance.yahoo.com
finance.yahoo.com/sectors/healthcare/articles/alcon-launches-clareon-truplus-enhanced-120300993.htmlAlcon Launches Clareon TruPlus, Enhanced Design ...
TruPlus is designed to increase depth of focus while maintaining the high-quality distance vision surgeons expect from a monofocal IOL1,2.
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