Post-Market Evaluation of the EVO ICL

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
EVO ICL	EVO ICL	STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism.

Primary Outcome Measures

Name	Time	Method
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg	1-6 hours postoperatively	The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG	1-6 hours postoperatively	The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

Secondary Outcome Measures

Name	Time	Method
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg	1-6 hours postoperatively	The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG	1-6 hours postoperatively	The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

Locations (8): Durrie Vision
🇺🇸
Overland Park, Kansas, United States
Key-Whitman Eye Center
🇺🇸
Dallas, Texas, United States
Aloha Laser Vision, LLC
🇺🇸
Honolulu, Hawaii, United States
Cleveland Eye Clinic
🇺🇸
Brecksville, Ohio, United States
Parkhurst NuVision
🇺🇸
San Antonio, Texas, United States
The Eye Institute of Utah
🇺🇸
Salt Lake City, Utah, United States
Kugler Vision, PC
🇺🇸
Omaha, Nebraska, United States
Vance Thompson Vision
🇺🇸
Sioux Falls, South Dakota, United States