Comparing different intraocular lenses for cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a prospective, randomized, multicenter trial that evaluates the effectiveness of three types of intraocular lenses: Clareon PanOptix, Clareon PanOptix Pro, and a mix of Clareon PanOptix Pro/Vivity in patients undergoing cataract surgery. The study is designed in two stages, with the first stage involving initial enrollment across three arms, followed by a head-to-head comparison based on the data collected. Participants will be masked to the treatment they receive, and the study aims to assess visual outcomes post-surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes.
* Ability to understand and sign an ethics committee-approved informed consent form.
* Willingness and ability to attend all scheduled study visits as required by the protocol.
* Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
* Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, or with a spherical IOL and LRIs or AKs resulting in a predicted postoperative astigmatism of less than 0.5 diopters (D).
* Ability to understand and complete questionnaires.

Exclusion Criteria:

* Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
* Ocular conditions that could confound study results, including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, preexisting retinal diseases such as macular degeneration or diabetic retinopathy.
* Any form of confirmed glaucomatous damage (ie, mild, moderate, or severe glaucoma).
* Participation in another clinical study that could interfere with the results.
* Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders).
* Subjects with nystagmus, strabismus, zonular laxity or dehiscence, and pseudoexfoliation.
* Prior ocular surgery (except for uncomplicated cataract surgery in the fellow eye).
* Participants desiring monovision.
* Any active ocular infection or inflammation (except for routine post-operative inflammation in the fellow eye)
* Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide accurate self-assessments.
* RMS total higher-order aberrations (HOAs) \>0.70 µm or coma \>0.40 µm as measured by tomography or topography with a 4 mm pupil setting.

Where it's running

• Shafer Vision Institute
  Plymouth Meeting, Pennsylvania, United States Recruiting
• Berkeley Eye Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Morgan Micheletti, MD — Berkeley Eye Center
• Study coordinator: Tetiana Huff
• Email: tetiana.huff@berkeleyeye.com
• Phone: 713-620-7640

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• MiLOOP-assisted cataract surgery for dense cataracts

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  Recruiting Universiti Kebangsaan Malaysia Medical Centre · Cheras, Kuala Lumpur · NCT07898007

• Visual adaptation and quality of life after different IOL implantation options

  This study follows adults who have cataracts and receive bilateral multifocal or mixed IOLs to see how their vision and daily life improve over 6 months.

  Recruiting Sichuan Academy of Medical Sciences · Chengdu · NCT07740590

• Corneal Biomechanics and Surgical Astigmatism after Cataract Surgery in Pseudoexfoliation

  This study tests how the cornea's biomechanical properties before cataract surgery relate to the amount of blinking surgically induced astigmatism, comparing people with pseudoexfoliation to those without.

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• Neuroplastic pain education and guided breathing during awake cataract surgery

  This trial tests whether the STEIN Protocol, a non-drug approach with pain education, guided imagery, and paced breathing, helps adults having cataract surgery require less pain medicine and feel less anxious.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07715591

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.