Clinical trial NCT05518539: Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
Official title: Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Newsom Eye & Laser Center
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2022-08-26
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for near, intermediate and distance vision, and who are considered appropriate candidates for trifocal lens implantation.

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.

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.

Primary outcomes:
measure: Binocular distance-corrected near (40 cm) visual acuity
timeFrame: 1 month postoperatively
measure: Binocular distance-corrected near (40 cm) visual acuity
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Binocular uncorrected distance (6 m) visual acuity
timeFrame: 1 and 3 months postoperative
measure: Binocular uncorrected intermediate (60 cm) visual acuity
timeFrame: 1 and 3 months postoperative
measure: Binocular uncorrected near (40 cm) visual acuity
timeFrame: 1 and 3 months postoperative
measure: Binocular corrected corrected distance (6 m) visual acuity
timeFrame: 1 and 3 months postoperative
measure: Binocular distance-corrected intermediate (60 cm) visual acuity
timeFrame: 1 and 3 months postoperative
measure: Manifest refraction
timeFrame: 1 and 3 months postoperative
measure: Satisfaction questionnaire
timeFrame: 3 months postoperative
measure: Visual disturbances questionnaire
timeFrame: 3 months postoperative
measure: Binocular distance corrected defocus curve
timeFrame: 3 months postoperative
Other outcomes:
measure: Binocular distance-corrected near (40 cm) visual acuity
timeFrame: 1 and 3 months postoperative
Locations:
city: Sebring
country: United States
facility: Newsom Eye & Laser Center
state: Florida
Study officials:
affiliation: Newsom Eye & Laser Center
name: Thomas H Newsom, MD
role: PRINCIPAL_INVESTIGATOR
References: