The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
Study Details
Study Description
Brief Summary
Prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Satisfaction, measured as the percentage of patients reporting "top box" satisfaction [6/1/20 - 7/1/20]
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.
Secondary Outcome Measures
- Percentage of postoperative patients who report overall satisfaction as either "satisfied" or "very satisfied." [6/1/20 - 7/1/20]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
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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:
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Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
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Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered intraocular lens, cystoid macular edema, etc.)
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Patients with greater than grade 1 posterior capsule opacity.
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Patient sin the historical reference set who underwent Astigmatic Keratotomy or Limbal Relaxing Incision during cataract surgery. -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Harvard Eye Associates | Laguna Hills | California | United States | 92653 |
| 2 | Quentin Allen | Palm City | Florida | United States | 34990-1913 |
| 3 | Quantum Vision Center | Edwardsville | Illinois | United States | 62025-3886 |
Sponsors and Collaborators
- Research Insight LLC
Investigators
- Study Director: John Hovanesian, MD, Research Insight LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALC51819219