CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Implantable Collamer Lensdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06229119
NCT06229119Phase 4Completed

Vault Evaluation After Implantation of an Implantable Collamer Lens

Carolina Eyecare Physicians, LLC·interventional·Posted Jan 29, 2024·Updated Mar 4, 2025

In Brief

A Phase 4 clinical trial evaluating Implantable Collamer Lens for Nearsightedness. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNearsightedness
CountriesUnited States
CollaboratorsScience in Vision

Timeline

Phase 4CompletedFinished
202420252026
First PostedJan 29, 2024
Enrollment StartJan 29, 2024
Primary CompletionAug 23, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.4 years ago

Interventions

Implantable Collamer Lensdevice

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.