The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction
1 other identifier
observational
60
1 country
3
Brief Summary
This will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the Panoptix or Panoptix Toric implant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2022
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedStudy Start
First participant enrolled
June 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2023
CompletedMarch 15, 2023
March 1, 2023
9 months
April 20, 2022
March 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"
Percentage of patients who notice glare or haloes around lights in dim light situations
Up to 6 months
Secondary Outcomes (2)
Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"
Up to 6 months
Percentage of postop patients who report they do not require reading glasses for various activities when asked "For what types of activities do you need glasses to see (other than sunglasses)?"
Up to 6 months
Other Outcomes (2)
Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?"
Up to 6 months
Percentage of patients who report "very satisfied" or " Somewhat satisfied" to the same question.
Up to 6 months
Interventions
Patients who previously underwent cataract surgery with the PanOptix or PanOptix Toric IOL in both eyes.
Eligibility Criteria
Adult patients undergoing cataract surgery.
You may qualify if:
- Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
- Patients implanted with Clareon PanOptix or Clareon Panoptix Toric lenses bilaterally within 6 months of the survey administration.
You may not qualify if:
- Patients with visually significant comorbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery
- Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
- Patients with previous refractive surgery within the past 6 months prior to cataract surgery
- Patients with \> grade 1 posterior capsule opacity at their last visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Harvard Eye Associates
Laguna Hills, California, 92653, United States
Florida Vision Institute
Stuart, Florida, 34994, United States
IllinEye Consulting
Evansville, Illinois, 62025, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2022
First Posted
April 26, 2022
Study Start
June 17, 2022
Primary Completion
March 10, 2023
Study Completion
March 10, 2023
Last Updated
March 15, 2023
Record last verified: 2023-03