The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance

Study Overview
=================
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.

Official Title
-----------------
The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance

Conditions
-----------------
Cataract Surgery

Intervention / Treatment
-----------------
* Device: Alcon PanOptix or PanOptix Toric IOL


Participation Criteria
=================
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 Patient sin the historical reference set who underwent Astigmatic Keratotomy or Limbal Relaxing Incision during cataract surgery. -
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Alcon PanOptix or PanOptix Toric IOL|Patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric IOL in both eyes.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction, measured as the percentage of patients reporting top box satisfaction | Primary objective: to determine the percentage of patients who report top box (5 out of 5) overall satisfaction on the questionnaire instrument. To determine the percentage of patients who report satisfaction (satisfied or very satisfied as 4 out of 5 on the attached questionnaire instrument. | 6/1/20 - 7/1/20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of postoperative patients who report overall satisfaction as either satisfied or very satisfied. | To report spectacle independence, measured as the percentage of patients who do not require glasses for each of the common activities queried like driving, reading, computer work, watching TV, and sports/hobbies. To determine the incidence of glare and halos described by the patient as a fair amount or worse (Question 20). | 6/1/20 - 7/1/20 |