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

NCT04146961 | Completed

• 1 other identifier: ALC51819219
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of postoperative patients who report overall satisfaction as either "satisfied" or "very satisfied."

  6/1/20 - 7/1/20

Interventions

Alcon PanOptix or PanOptix Toric IOL DEVICE

Patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric IOL in both eyes.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Research Insight LLC: lead

Study Sites (3)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Quentin Allen

Palm City, Florida, 34990-1913, United States

Location

Quantum Vision Center

Edwardsville, Illinois, 62025-3886, United States

Location

Study Officials

• John Hovanesian, MD

  Research Insight LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 31, 2019
• Study Start: October 5, 2019
• Primary Completion: April 10, 2020
• Study Completion: July 21, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-01

Locations

US (3)