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Vault Evaluation After ICL Implantation

NCT06229119 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-04

Study results available
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Summary

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.

Conditions

  • Nearsightedness

Interventions

DEVICE

Implantable Collamer Lens

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.

Sponsors & Collaborators

  • Science in Vision

    collaborator OTHER

  • Carolina Eyecare Physicians, LLC

    lead OTHER

Principal Investigators

  • Kerry Solomon, MD · Carolina Eyecare Physicians

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2024-08-23
Completion
2024-08-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06229119 on ClinicalTrials.gov