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Completed

NCT Number: NCT05538754

Post-Market Evaluation of the EVO ICL

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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Key information

Conditions

Myopia Astigmatism Eye Diseases Myopic Astigmatism Refractive Errors

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aloha Laser Vision, LLC, Honolulu, Hawaii, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVO ICL

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.

Primary outcomes

  1. 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.

  2. 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

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

    Time frame: 1-6 hours postoperatively

    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.

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

    Time frame: 1-6 hours postoperatively

    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.

Other outcomes

  1. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

    Time frame: 1-6 hours postoperatively

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

  2. Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

    Time frame: 1-6 hours postoperatively

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

  3. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

    Time frame: Day 1 postoperatively

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

  4. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

    Time frame: Day 1 postoperatively

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

  5. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

    Time frame: Day 5-9 postoperatively

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

  6. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

    Time frame: Day 5-9 postoperatively

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

  7. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD

    Time frame: Day 10-18 postoperatively

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

  8. Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes

    Time frame: Day 10-18 postoperatively

    Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes

Sponsors and collaborators

Lead sponsor

Staar Surgical Company

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2022
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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