Clareon PanOptix Pro vs. Clareon PanOptix - Study A
- Conditions
- PresbyopiaAphakia
- Interventions
- Device: CPO Pro IOLDevice: CPO IOLProcedure: Cataract surgery
- Registration Number
- NCT06400745
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.
- Detailed Description
Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- Understand and sign an ethics committee-approved informed consent form;
- Willing and able to attend all scheduled study visits as required by the protocol;
- Planned cataract surgery (both eyes);
- Preoperative corneal astigmatism less that 1.00 diopter in each eye.
- Other protocol-defined inclusion criteria may apply.
Key
- Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;
- Ocular conditions as specified in the protocol;
- Subjects who desire monovision correction.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CPO Pro IOL CPO Pro IOL CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery. CPO Pro IOL CPO IOL CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery. CPO IOL CPO Pro IOL CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery. CPO Pro IOL Cataract surgery CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery. CPO IOL CPO IOL CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery. CPO IOL Cataract surgery CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
- Primary Outcome Measures
Name Time Method Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Month 2 postoperative Visual Acuity (VA) will be assessed for each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA will be measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Wolstan & Goldberg Eye Associates
🇺🇸Torrance, California, United States
Grosinger, Spigelman & Grey Eye Surgeons, P.C.
🇺🇸Bloomfield Hills, Michigan, United States
Moyes Eye Center
🇺🇸Kansas City, Missouri, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Carolina Eyecare Physicians, LLC
🇺🇸Mount Pleasant, South Carolina, United States
Vision for Life
🇺🇸Nashville, Tennessee, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
The Eye Institute of Utah
🇺🇸Salt Lake City, Utah, United States