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

NCT ID: NCT04146961

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-05

Study Completion Date

2020-07-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Cataract Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Alcon PanOptix or PanOptix Toric IOL

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

Intervention Type DEVICE

Eligibility Criteria

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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. -
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research Insight LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Hovanesian, MD

Role: STUDY_DIRECTOR

Research Insight LLC

Locations

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Harvard Eye Associates

Laguna Hills, California, United States

Site Status

Quentin Allen

Palm City, Florida, United States

Site Status

Quantum Vision Center

Edwardsville, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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ALC51819219

Identifier Type: -

Identifier Source: org_study_id

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