Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 71
- Locations
- 12
- Primary Endpoint
- Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Study Overview
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 6 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: CPO Pro IOL (Device)
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.
Intervention: Cataract Surgery (Procedure)
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.
Intervention: CPO IOL (Device)
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.
Intervention: CPO Pro IOL (Device)
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.
Intervention: CPO IOL (Device)
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.
Intervention: Cataract Surgery (Procedure)
Outcomes
Primary Outcomes
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Time Frame: Month 2 postoperative
Visual Acuity (VA) was 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 was 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 Outcomes
No secondary outcomes reported