Clinical trial NCT05518227: Patient Satisfaction and Visual Outcomes After Bilateral PanOptix Implantation in Patients With Previous Multifocal Contact Lens
Official title: Patient Satisfaction and Visual Outcomes After Bilateral PanOptix Implantation in Patients With Previous Multifocal Contact Lens
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cataract
Lead sponsor: Vivid Laser Center
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2022-08-26
Enrollment: 12
Sex: ALL
Standard ages: CHILD
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 spectacle independence and patient satisfaction and visual outcomes after bilateral PanOptix implantation in patients with previous multifocal contact lens experience.

Detailed description: This study is a single-arm unmasked clinical evaluation study of patient satisfaction after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 week 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.

* Adult cataract patients undergoing uncomplicated cataract surgery with Clareon PanOptix IOL implantation (non-toric/toric).
* Visually significant cataracts bilaterally.
* History of successful soft multifocal contact lens use in the past (within ≤ last 5 years).
* Healthy ocular exam.
* Gender: Males and Females.
* 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.

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.

* Previous monovision patients.
* Ocular comorbidity that might hamper post operative visual acuity (Uveitis, Keratoconus, Retinopathies, Glaucoma).
* Previous ocular or refractive surgery.
* Expected monocular post-op distance VA worse than 20/25 (Snellen) in either eye.
* Refractive lens exchange.
* Angle kappa measurement in a single eye over 0.6 mm.
* Irregular corneal astigmatism or ectasia.
* Difficulties comprehending written or spoken English language.
* Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
* Severe/uncontrolled Ocular surface disease/Dry Eye Disease.
* Intraoperative complications during procedure.
* Visual expectations exceed outcomes.
* Strabismus (with or without amblyopia).

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: Satisfaction questionnaire
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Binocular uncorrected distance visual acuity (6m)
timeFrame: 3 months postoperative
measure: Binocular uncorrected intermediate visual acuity (60 cm)
timeFrame: 3 months postoperative
measure: Binocular uncorrected near visual acuity (40 cm)
timeFrame: 3 months postoperative
measure: Binocular corrected distance visual acuity (6m)
timeFrame: 3 months postoperative
measure: Binocular distance corrected intermediate visual acuity (60 cm)
timeFrame: 3 months postoperative
measure: Binocular distance corrected intermediate visual acuity (40 cm)
timeFrame: 3 months postoperative
measure: Manifest refraction
timeFrame: 3 months postoperative
measure: Spectacle independence
timeFrame: 3 months postoperative
Other outcomes:
measure: Binocular distance corrected intermediate visual acuity (33 cm)
timeFrame: 3 months postoperative
measure: Visual disturbances questionnaire
timeFrame: 3 months postoperative
Locations:
city: Kelowna
country: Canada
facility: Vivid Laser Center
state: British Columbia
Study officials:
affiliation: Vivid Laser Center
name: Ronald Baldassare, MD
role: PRINCIPAL_INVESTIGATOR
References: