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PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

NCT04884672 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 237

Last updated 2023-10-23

No results posted yet for this study

Summary

The primary objective of this PMCF investigation is to systematically collect safety and effectiveness data with the VISUMAX 800 laser in clinical daily routine SMILE use for the purpose of post market surveillance.

Conditions

  • Myopia
  • Astigmatism

Interventions

DEVICE

SMILE

Small incision lenticule extraction, a refractive surgery procedure for the corrcetion of myopia with or without astigmatism

Sponsors & Collaborators

  • In Vitro Research Solutions Pvt Ltd (iVRS)

    collaborator UNKNOWN

  • Carl Zeiss Meditec AG

    lead INDUSTRY

Principal Investigators

  • Jesper Hjortdal, Prof. · Department of Clinical Medicine - Department of Ophthalmology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2023-03-25
Completion
2023-03-25

Countries

  • Denmark
  • Germany
  • Hong Kong
  • India

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 NCT04884672 on ClinicalTrials.gov