The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The PanOptix trifocal lens by Alcon was introduced in 2015 and is currently in use in over 70 countries. Its outcomes on the AcrySof platform are well documented and highly appealing to patients and clinicians.,, Clinicians no longer need to routinely target monovision or modified monovision to provide a range of vision. With the release of the Clareon material for this lens, questions remain about how the new lens material will influence patient satisfaction and uncorrected visual performance.
Study Design
Outcome Measures
Primary Outcome Measures
- 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?" [Up to 6 months]
Percentage of patients who notice glare or haloes around lights in dim light situations
Secondary Outcome Measures
- Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?" [Up to 6 months]
How often do you need glasses to see the computer.
- 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]
Percentage of postoperative patients who report that they do not require glasses for varous activities.
Other Outcome Measures
- 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 satisfied with their vision after surgery
- Percentage of patients who report "very satisfied" or " Somewhat satisfied" to the same question. [Up to 6 months]
Percentage of patients who report "very satisfied" or " Somewhat satisfied" to the same question.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
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Patients implanted with Clareon PanOptix or Clareon Panoptix Toric lenses bilaterally within 6 months of the survey administration.
Exclusion Criteria:
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Patients with visually significant comorbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery
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Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
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Patients with previous refractive surgery within the past 6 months prior to cataract surgery
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Patients with > grade 1 posterior capsule opacity at their last visit
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Harvard Eye Associates | Laguna Hills | California | United States | 92653 |
| 2 | Florida Vision Institute | Stuart | Florida | United States | 34994 |
| 3 | IllinEye Consulting | Evansville | Illinois | United States | 62025 |
Sponsors and Collaborators
- Research Insight LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2111 Clareon PanOptix