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Panoptix Trifocal Lens in Post Refractive Myopic Laser Vision Correction Surgery

NCT04698278 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2021-03-17

No results posted yet for this study

Summary

The two main objectives of this study are to demonstrate safety and effectiveness of implanting the PanOptix Trifocal IOL in patients who have had previous myopic Lasik. The primary objectives to demonstrate clinical safety will be the quality of vision questionnaire (QUVID) which will demonstrate the patient's perception of halos, glares, and starbursts before and after the implantation of the trifocal IOL.

The primary objective to demonstrate clinical effectiveness will be done by measuring visual outcomes at distance, intermediate, and near. In addition, the patients will also fill out the spectacle independence questionnaire (IOLSAT Questionnaire) to determine their level of glasses independence postoperatively. In addition, at the conclusion of the study the patient will also fill out a patient satisfaction survey.

Conditions

  • Cataract
  • Refractive Errors

Interventions

DEVICE

PanOptix Trifocal Intraocular Lens

This is a FDA approved trifocal lens that will be placed in patients who have had previous myopic LASIK or PRK.

Sponsors & Collaborators

  • Alcon Research

    collaborator INDUSTRY

  • Parkhurst NuVision Clinical Research LLC

    lead OTHER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2022-01-01
Completion
2022-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04698278 on ClinicalTrials.gov