Vault Evaluation After ICL Implantation

NCT ID: NCT06229119

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2024-08-23

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICL

ICL implantation

Group Type: OTHER

Implantable Collamer Lens

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Science in Vision

OTHER

Sponsor Role: collaborator

Carolina Eyecare Physicians, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerry Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Carolina Eyecare Physicians

Locations

Helga Sandoval

Mt. Pleasant, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CEP 23-003

Identifier Type: -

Identifier Source: org_study_id