Comparing different intraocular lenses for cataract surgery
A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects
This study is testing three different types of lenses used in cataract surgery to see which one helps people see better after the procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Berkeley Eye Center Academic / other |
| Locations | 2 sites (Plymouth Meeting, Pennsylvania and 1 other locations) |
| Trial ID | NCT06922084 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older who are scheduled for cataract surgery in both eyes and meet specific visual acuity and astigmatism criteria.
Not a fit: Patients with significant ocular conditions or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the best intraocular lens options for improved visual outcomes in cataract patients.
How similar studies have performed: Other studies have explored various intraocular lenses, but this specific comparison of these three types is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Plymouth Meeting, Pennsylvania and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.