Status:
COMPLETED
Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)
Lead Sponsor:
Staar Surgical Company
Conditions:
Myopia
Myopic Astigmatism
Eligibility:
All Genders
21-45 years
Phase:
NA
Brief 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 diagno...
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT04283149
Start Date
January 30 2020
End Date
December 15 2023
Last Update
March 7 2025
Active Locations (14)
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1
Barnett Dulaney Perkins
Phoenix, Arizona, United States, 85106
2
Aloha Laser Vision, LLC
Honolulu, Hawaii, United States, 96814
3
Price Vision Group,
Indianapolis, Indiana, United States, 46260
4
Durrie Vision
Overland Park, Kansas, United States, 66210