Post-Market Evaluation of the EVO ICL

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-23

Study Completion Date

2023-10-04

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Myopia Myopic Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EVO ICL

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

Group Type OTHER

EVO ICL

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No