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OpenTrials
Completed

NCT Number: NCT06229119

Vault Evaluation After ICL Implantation

The purpose of this study is to evaluate the lens vault after implantation of an implantable collamer lens (ICL). The ICL is designed to be implanted in front of the eye, without removing the natural lens. Because of this, it is also known as a phakic IOL. The ICL has already been approved by the U.S. Food and Drug Administration (FDA) to treat mid to high degrees of refractive errors such nearsightedness (also called myopia) with or without astigmatism. Once the artificial lens is implanted, a space between the ICL and the crystalline lens is created, which is called vault.

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Key information

Conditions

Nearsightedness Eye Diseases Myopia Refractive Errors

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helga Sandoval

Mt. Pleasant, South Carolina, 29464, United States

About this study

The ICL will be implanted in both eyes of study subjects. Diagnostic instrumentation will be used to measure the vault between the ICL and the crystalline lens.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gender: Males and Females.
  • Age: 21 to 45 years of age
  • Willing and able to provide written informed consent for participation in the study
  • Willing and able to comply with scheduled visits and other study procedures.
  • Scheduled to undergo ICL implantation in both eyes within 1 to 30 days between surgeries.
  • Subjects who require an ICL power in the range of -3.00 to -15.00 D.

Exclusion criteria

  • Patients who do not qualify for an ICL according to the Direction For Use (DFU)
  • Unstable or worsening myopia
  • Use of any systemic or topical drug known to interfere with visual performance.
  • Irregular astigmatism.
  • History of retinal detachment.
  • Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
  • Pigment dispersion
  • Previous intraocular surgery.
  • Previous refractive surgery.
  • Previous keratoplasty
  • Pupil abnormalities
  • Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
  • Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Treatment and study plan

Implantable Collamer Lens

Device

The EVO ICL lens is intended to be placed entirely within the posterior chamber directly behind the iris and in front of the anterior capsule of the human crystalline lens. When correctly positioned, the EVO ICL lens functions as a refractive element to optically reduce moderate to high myopia with or without astigmatism.

Primary outcomes

  1. Mean Difference Between Predicted and Actual Central Vault at 1-month After ICL Implantation

    Time frame: 1-month

    Difference between the predicted vault at the preoperative visit and the actual vault measured at the 1-month visit

Sponsors and collaborators

Lead sponsor

Carolina Eyecare Physicians, LLC

Other

Collaborators

  • Science in Vision

Registry information

Official study title

Vault Evaluation After Implantation of an Implantable Collamer Lens

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
Mar 4, 2025

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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