Post-Market Evaluation of the EVO ICL

Staar Surgical Company205 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

205

Conditions

Myopia Myopic Astigmatism

Interventions

EVO ICLDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (8)

Aloha Laser Vision, LLC

Honolulu, Hawaii, United States

Durrie Vision

Overland Park, Kansas, United States

Kugler Vision, PC

Omaha, Nebraska, United States

Cleveland Eye Clinic

Brecksville, Ohio, United States

Outcomes

Primary Outcomes

Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg

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.

Time frame: 1-6 hours postoperatively

Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG

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.

Time frame: 1-6 hours postoperatively

Secondary Outcomes

Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg

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.

Time frame: 1-6 hours postoperatively

Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG

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.

Time frame: 1-6 hours postoperatively

Data from ClinicalTrials.gov

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