Post-Market Evaluation of the EVO ICL

Sponsor

Staar Surgical Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05538754

Collaborator

(none)

200

Enrollment

Locations

Arm

22.6

Anticipated Duration (Months)

28.6

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Myopia Myopic Astigmatism	Device: EVO ICL	N/A

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

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All enrolled subjects will undergo phakic eye surgery to have the STAAR EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.All enrolled subjects will undergo phakic eye surgery to have the STAAR EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Post-Market Evaluation of the EVO ICL

Actual Study Start Date :

Sep 14, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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