Post-Market Evaluation of the EVO ICL

Myopia Clinical Trial

Official title:

Post-Market Evaluation of the EVO ICL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05538754
• Other study ID #: CP22-01
• Status: Completed
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: October 4, 2023

Study information

• Verified date: January 2024
• Source: Staar Surgical Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: October 4, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Myopic Astigmatism

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Key-Whitman Eye Center	Dallas	Texas
United States	Aloha Laser Vision, LLC	Honolulu	Hawaii
United States	Kugler Vision, PC	Omaha	Nebraska
United States	Durrie Vision	Overland Park	Kansas
United States	The Eye Institute of Utah	Salt Lake City	Utah
United States	Parkhurst NuVision	San Antonio	Texas
United States	Vance Thompson Vision	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Staar Surgical Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elevated Intraocular Pressure (IOP) in Primary Eyes	The proportion of primary (i.e. first implanted) eyes that have IOP = 30 mmHg and IOP =40 mmHG	1-6 hours postoperatively
Secondary	Elevated Intraocular Pressure (IOP) in Fellow Eyes	The proportion of fellow eyes that have IOP = 30 mmHg and IOP =40 mmHG	1-6 hours postoperatively