Post-Market Evaluation of the EVO ICL
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).
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.
Arms and Interventions
|Other: EVO ICL
STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism.
Device: EVO ICL
The EVO ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Primary Outcome Measures
- Elevated Intraocular Pressure (IOP) in Primary Eyes [1-6 hours postoperatively]
The proportion of primary (i.e. first implanted) eyes that have IOP ≥ 30 mmHg and IOP ≥40 mmHG
Secondary Outcome Measures
- Elevated Intraocular Pressure (IOP) in Fellow Eyes [1-6 hours postoperatively]
The proportion of fellow eyes that have IOP ≥ 30 mmHg and IOP ≥40 mmHG
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.
Ocular hypertension or glaucoma.
Insulin dependent diabetes or diabetic retinopathy.
History of previous ocular surgery.
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.
Contacts and Locations
|1||Durrie Vision||Overland Park||Kansas||United States||66210|
|2||Kugler Vision, PC||Omaha||Nebraska||United States||68118|
|3||Cleveland Eye Clinic||Brecksville||Ohio||United States||44141|
|4||Vance Thompson Vision||Sioux Falls||South Dakota||United States||57108|
|5||Key-Whitman Eye Center||Dallas||Texas||United States||75243|
|6||Parkhurst NuVision||San Antonio||Texas||United States||78229|
|7||The Eye Institute of Utah||Salt Lake City||Utah||United States||84107|
Sponsors and Collaborators
- Staar Surgical Company
- Study Director: Joanne Egamino, PhD, Staar Surgical Company
Study Documents (Full-Text)None provided.