Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 87
- Locations
- 16
- 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.
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.
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