The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction

NCT ID: NCT05346172

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-17

Study Completion Date

2023-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PanOptix or PanOptix Toric IOL

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Research Insight LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Harvard Eye Associates

Laguna Hills, California, United States

Site Status

Florida Vision Institute

Stuart, Florida, United States

Site Status

IllinEye Consulting

Evansville, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2111 Clareon PanOptix

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.