Post-Market Evaluation of the EVO ICL
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Staar Surgical Company
- Enrollment
- 205
- Locations
- 8
- Primary Endpoint
- Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
EVO ICL
STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism.
Intervention: EVO ICL (Device)
Outcomes
Primary Outcomes
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg
Time Frame: 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
Time Frame: 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 Outcomes
- Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg(1-6 hours postoperatively)
- Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG(1-6 hours postoperatively)