Clinical trial NCT05538754: Post-Market Evaluation of the EVO ICL
Official title: Post-Market Evaluation of the EVO ICL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Myopic Astigmatism
Keywords: nearsightedness
phakic IOL
toric ICL
ICL
TICL
EVO
astigmatism
Lead sponsor: Staar Surgical Company
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 205
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled subjects will undergo phakic eye surgery to have the STAAR EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).

Detailed description: This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience and training to implant the EVO/EVO+ lens.

Eligibility criteria: Inclusion Criteria:

* Moderate to high myopia correctable with available EVO ICL powers.
* Moderate to high myopic with astigmatism correctable with available EVO ICL powers.
* Stable refractive history within 0.50 D cylinder for 1 year prior to implantation.
* Stable refractive history within 0.50 D for spherical equivalent 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:

* Ocular hypertension or glaucoma.
* Insulin dependent diabetes or diabetic retinopathy.
* History of previous ocular surgery.
* Monocular.
* Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg
timeFrame: 1-6 hours postoperatively
measure: Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG
timeFrame: 1-6 hours postoperatively
Secondary outcomes:
measure: Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg
timeFrame: 1-6 hours postoperatively
measure: Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG
timeFrame: 1-6 hours postoperatively
Other outcomes:
measure: Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
timeFrame: 1-6 hours postoperatively
measure: Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
timeFrame: 1-6 hours postoperatively
measure: Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
timeFrame: Day 1 postoperatively
measure: Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
timeFrame: Day 1 postoperatively
measure: Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
timeFrame: Day 5-9 postoperatively
measure: Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
timeFrame: Day 5-9 postoperatively
measure: Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
timeFrame: Day 10-18 postoperatively
measure: Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
timeFrame: Day 10-18 postoperatively
Locations:
city: Honolulu
country: United States
facility: Aloha Laser Vision, LLC
state: Hawaii
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
city: Omaha
country: United States
facility: Kugler Vision, PC
state: Nebraska
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
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: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
Study officials:
affiliation: Staar Surgical Company
name: Joanne Egamino, PhD
role: STUDY_DIRECTOR
References: