Clareon PanOptix Pro vs. Clareon PanOptix - Study B
- Conditions
- AphakiaPresbyopia
- Registration Number
- NCT06401551
- 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
- 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
Related Research Topics
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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 Eye Care Physicians
🇺🇸Charleston, 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
Wolstan & Goldberg Eye Associates🇺🇸Torrance, California, United States