Multicenter Clinical Trial of a Phakic Implantable Collamer Lens (ICL)

  • STATUS
    Recruiting
  • participants needed
    333
  • sponsor
    Staar Surgical Company
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Updated on 19 February 2024
See if I qualify
astigmatism
myopia
severe myopia

Summary

This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian Implantable Collamer Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.

Description

This study will be conducted at up to 20 clinical sites in the United States by surgeons qualified by training and experience to implant STAAR ICLs.

Details
Condition Myopia, Myopia, Myopic Astigmatism
Age 21years - 45years
Treatment EVO Visian ICL for Myopia, EVO Visian Toric ICL for Myopia with Astigmatism, EVO+ Visian ICL for Myopia, EVO+ Visian Toric ICL for Myopia with Astigmatism
Clinical Study IdentifierNCT04283149
SponsorStaar Surgical Company
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Moderate to high myopia or myopic astigmatism correctable with available EVO/EVO+ ICL powers
Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation
Able and willing to return for scheduled follow-up examinations after surgery
Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations
Other protocol-specified inclusion criteria may apply

Exclusion Criteria

Insulin-dependent diabetes or diabetic retinopathy
History of previous ocular surgery
Cataract of any grade
Monocular
Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study
Other protocol-specified exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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