Clinical trial NCT04146961: The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
Official title: The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Surgery
Lead sponsor: Research Insight LLC
Sponsor class: INDUSTRY
First posted: 2019-10-31
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Investigators will collect patient-reported outcomes data on 60 new patients where both eyes receive either a PanOptix or PanOptix Toric lens, depending on the correction needed for each eye to eliminate astigmatism and achieve the target refraction. Both eyes will be targeted for emmetropia. Patients will be screened based on their candidacy for a multifocal implant.

Brief summary: Prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes.

Detailed description: This will be an open-label, prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes, comparing to an existing historical dataset of patient reported outcomes with bilateral ReSTOR 3.0 implants.

Eligibility criteria: Inclusion Criteria:

* Patients implanted with the PanOptix or Panoptix Toric lenses bilaterally within 6 months of the survey administration. Patients may have the toric version of this lens in neither eye, one eye, or both eyes.
* Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
* Patients whose spherical equivalent outcome is within 0.5D of target and whose magnitude of manifest postoperative cylinder is less than or equal to 0.75 diopters.

Exclusion Criteria:

* Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered intraocular lens, cystoid macular edema, etc.)
* Patients with greater than grade 1 posterior capsule opacity.
* Patient sin the historical reference set who underwent Astigmatic Keratotomy or Limbal Relaxing Incision during cataract surgery. -

Primary outcomes:
measure: Satisfaction, measured as the percentage of patients reporting "top box" satisfaction
timeFrame: 6/1/20 - 7/1/20
Secondary outcomes:
measure: Percentage of postoperative patients who report overall satisfaction as either "satisfied" or "very satisfied."
timeFrame: 6/1/20 - 7/1/20
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Palm City
country: United States
facility: Quentin Allen
state: Florida
city: Edwardsville
country: United States
facility: Quantum Vision Center
state: Illinois
Study officials:
affiliation: Research Insight LLC
name: John Hovanesian, MD
role: STUDY_DIRECTOR
References: