The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction

Cataract Clinical Trial

Official title:

The Clareon PanOptix Trifocal IOL: A Study of Patient Satisfaction and Visual Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346172
• Other study ID #: 2111 Clareon PanOptix
• Status: Completed
• Start date: June 17, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: March 2023
• Source: Research Insight LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• PanOptix or PanOptix Toric IOL
Patients who previously underwent cataract surgery with the PanOptix or PanOptix Toric IOL in both eyes.

Locations

Country	Name	City	State
United States	IllinEye Consulting	Evansville	Illinois
United States	Harvard Eye Associates	Laguna Hills	California
United States	Florida Vision Institute	Stuart	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Research Insight LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?"	Percentage of patients satisfied with their vision after surgery	Up to 6 months
Other	Percentage of patients who report "very satisfied" or " Somewhat satisfied" to the same question.	Percentage of patients who report "very satisfied" or " Somewhat satisfied" to the same question.	Up to 6 months
Primary	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	Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"	How often do you need glasses to see the computer.	Up to 6 months
Secondary	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)?"	Percentage of postoperative patients who report that they do not require glasses for varous activities.	Up to 6 months