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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518539
• Other study ID #: THN-22-001
• Status: Recruiting
• Start date: September 8, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Newsom Eye & Laser Center
• Contact: Jaime Dixon
• Phone: 863-385-1544
• Email: j.dixon[@]newsomeye.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• The Clareon™ PanOptix™ Trifocal (toric and non-toric models)
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)

Locations

Country	Name	City	State
United States	Newsom Eye & Laser Center	Sebring	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Newsom Eye & Laser Center	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Binocular distance-corrected near (40 cm) visual acuity		1 and 3 months postoperative
Primary	Binocular distance-corrected near (40 cm) visual acuity		1 month postoperatively
Primary	Binocular distance-corrected near (40 cm) visual acuity		3 months postoperatively
Secondary	Binocular uncorrected distance (6 m) visual acuity		1 and 3 months postoperative
Secondary	Binocular uncorrected intermediate (60 cm) visual acuity		1 and 3 months postoperative
Secondary	Binocular uncorrected near (40 cm) visual acuity		1 and 3 months postoperative
Secondary	Binocular corrected corrected distance (6 m) visual acuity		1 and 3 months postoperative
Secondary	Binocular distance-corrected intermediate (60 cm) visual acuity		1 and 3 months postoperative
Secondary	Manifest refraction	Including residual spherical equivalent refraction, residual sphere, and residual astigmatism	1 and 3 months postoperative
Secondary	Satisfaction questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months postoperative
Secondary	Visual disturbances questionnaire	Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.	3 months postoperative
Secondary	Binocular distance corrected defocus curve		3 months postoperative