Clinical trial NCT04283149: Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)
Official title: A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Myopic Astigmatism
Keywords: Nearsightedness
Phakic intraocular lens (IOL)
ICL
Toric ICL
EVO
EVO+
Visian
Lead sponsor: Staar Surgical Company
Sponsor class: INDUSTRY
First posted: 2020-02-25
Enrollment: 327
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled eyes will undergo phakic eye surgery to have one of the available implantable collamer lenses EVO or EVO+ (spherical or toric) ICL implanted in their primary eye. Fellow eye surgery will occur between 7 and 14 days after primary eye surgery.
Primary purpose: TREATMENT

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 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.

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 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.

Primary outcomes:
measure: Number of Primary Eyes Requiring Peripheral Iridotomy (PI)
timeFrame: 6 Months
measure: Endothelial Cell Density (ECD) Change in Primary Eyes.
timeFrame: 6 Months
measure: Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
timeFrame: 6 months
measure: Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
timeFrame: 6 months
measure: Number of Ocular Adverse Events (AEs) in Primary Eyes.
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)
timeFrame: 6 Months
measure: Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.
timeFrame: 6 Months
measure: Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.
timeFrame: 6 months
measure: Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.
timeFrame: 6 months
measure: Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes
timeFrame: 6 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barnett Dulaney Perkins
state: Arizona
city: Honolulu
country: United States
facility: Aloha Laser Vision, LLC
state: Hawaii
city: Indianapolis
country: United States
facility: Price Vision Group,
state: Indiana
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
city: Bowie
country: United States
facility: Solomon Eye Physicians and Surgeons/Bowie Vision Institute
state: Maryland
city: Saint Louis
country: United States
facility: Brinton Vision
state: Missouri
city: Omaha
country: United States
facility: Kugler Vision, PC
state: Nebraska
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: King Of Prussia
country: United States
facility: Kremer Eye Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
city: Draper
country: United States
facility: Hoopes Vision/Hoopes, Durrie, Rivera Research
state: Utah
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
Study officials:
affiliation: VP, Global Clinical Affairs
name: Joanne Egamino, PhD
role: STUDY_DIRECTOR
References: