Clinical trial NCT05346172: The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction
Official title: The Clareon PanOptix Trifocal IOL: A Study of Patient Satisfaction and Visual Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Research Insight LLC
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing cataract surgery.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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?"
timeFrame: Up to 6 months
Secondary outcomes:
measure: Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"
timeFrame: Up to 6 months
measure: 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)?"
timeFrame: Up to 6 months
Other outcomes:
measure: Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?"
timeFrame: Up to 6 months
measure: Percentage of patients who report "very satisfied" or " Somewhat satisfied" to the same question.
timeFrame: Up to 6 months
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Stuart
country: United States
facility: Florida Vision Institute
state: Florida
city: Evansville
country: United States
facility: IllinEye Consulting
state: Illinois
Study officials:
References: