NCT06229119

Vault Evaluation After ICL Implantation

Vault Evaluation After Implantation of an Implantable Collamer Lens

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Carolina Eyecare Physicians, LLC · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Nearsightedness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-29
• Primary completion: 2024-08-23
• Completion: 2024-08-23
• First posted: 2024-01-29
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study