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N/A N=30

Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens

Cataract

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Binocular Distance-corrected Near (40 cm) Visual Acuity — 0.00 logMAR

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
The Clareon™ PanOptix™ Trifocal (toric and non-toric models) (Device)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Newsom Eye & Laser Center
Primary completion
Jun 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Binocular Distance-corrected Near (40 cm) Visual Acuity
0.01
PRIMARY
Binocular Distance-corrected Near (40 cm) Visual Acuity
0.01
SECONDARY
Binocular Uncorrected Distance (6 m) Visual Acuity
0.00; 0.02
SECONDARY
Binocular Uncorrected Intermediate (60 cm) Visual Acuity
-0.04; -0.08
SECONDARY
Binocular Uncorrected Near (40 cm) Visual Acuity
0.04; 0.04
SECONDARY
Binocular Corrected Corrected Distance (6 m) Visual Acuity
-0.02; -0.04
SECONDARY
Binocular Distance-corrected Intermediate (60 cm) Visual Acuity
-0.04; -0.08
SECONDARY
Manifest Refraction
46; 46
SECONDARY
Satisfaction Questionnaire
24; 22; 17
SECONDARY
Visual Disturbances Questionnaire
3; 2; 0; 0; 0; 0

Summary

To evaluate visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens (IOL) targeted for emmetropia.

Eligibility Criteria

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

  • Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a trifocal IOL
  • Meet the requirements for on-label implantation of the trifocal IOL
  • Gender: Males and Females.
  • Age: 40 or older.
  • Willing and able to provide written informed consent for participation in the study.
  • Willing and able to comply with scheduled visits and other study procedures.
  • Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract).
  • Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.
  • All eyes will be in the range of availability for Clareon PanOptix IOL and Clareon PanOptix Toric IOL. For cylinder below the Toric IOL indication (T3), an LRI will be used during surgery.

Exclusion Criteria

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

  • Patients with any corneal pathology (including corneal dystrophies, scaring, severe dry eye syndrome, irregular astigmatism, HOA) limiting or affecting visual potential.
  • Patients with previous corneal refractive surgery.
  • Patients with pre-existing ocular pathology, including maculopathy, ARMD, ERM, prior RD, and glaucoma limiting or affecting visual potential.
  • Subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
  • Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05518539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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