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OpenTrials
Completed

NCT Number: NCT04146961

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

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

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Key information

Conditions

Cataract Surgery

Sex eligibility

All sexes

Study type

Observational

Primary location

Harvard Eye Associates, Laguna Hills, California, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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  • Patient sin the historical reference set who underwent Astigmatic Keratotomy or Limbal Relaxing Incision during cataract surgery. -

Treatment and study plan

Alcon PanOptix or PanOptix Toric IOL

Device

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

Primary outcomes

  1. Satisfaction, measured as the percentage of patients reporting "top box" satisfaction

    Time frame: 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 outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Research Insight LLC

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2019
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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