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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05518539

Enrollment

Registered

2022-08-26

Start date

2022-09-08

Completion date

2024-06-14

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

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

Detailed description

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

Interventions

DEVICEThe Clareon™ PanOptix™ Trifocal (toric and non-toric models)

Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Binocular Distance-corrected Near (40 cm) Visual Acuity	1 month postoperatively

Secondary

Measure	Time frame	Description
Binocular Uncorrected Distance (6 m) Visual Acuity	1 and 3 months postoperative	—
Binocular Uncorrected Intermediate (60 cm) Visual Acuity	1 and 3 months postoperative	—
Binocular Uncorrected Near (40 cm) Visual Acuity	1 and 3 months postoperative	—
Binocular Corrected Corrected Distance (6 m) Visual Acuity	1 and 3 months postoperative	—
Binocular Distance-corrected Intermediate (60 cm) Visual Acuity	1 and 3 months postoperative	—
Manifest Refraction	3 months postoperative	spherical equivalent refraction and astigmatism less than or equal to 0.5 D.
Satisfaction Questionnaire	3 months postoperative	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding Never or Rarely) divided by (# of subjects) times 100. A higher percentage is a better outcome.
Visual Disturbances Questionnaire	3 months postoperative	Questionnaire for Visual Disturbances (QUVID).

Countries

United States

Participant flow

Participants by arm

Arm	Count
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models) Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)	30
Total	30

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	6

Baseline characteristics

Characteristic	The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)	—
Age, Continuous	65.0 years STANDARD_DEVIATION 7.7	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	20 Participants	—
Sex: Female, Male Male	10 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 30
other Total, other adverse events	0 / 30
serious Total, serious adverse events	0 / 30

Outcome results

Primary

Binocular Distance-corrected Near (40 cm) Visual Acuity

Time frame: 3 months postoperatively

Arm	Measure	Value (MEAN)	Dispersion
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)	Binocular Distance-corrected Near (40 cm) Visual Acuity	0.01 logMAR	Standard Deviation 0.1

Primary

Binocular Distance-corrected Near (40 cm) Visual Acuity

Time frame: 1 month postoperatively

Arm	Measure	Value (MEAN)	Dispersion
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)	Binocular Distance-corrected Near (40 cm) Visual Acuity	0.00 logMAR	Standard Deviation 0.06

Secondary