Vault Evaluation After ICL Implantation

NCT06229119 | Completed Phase 4 Results FDA Device

• 1 other identifier: CEP 23-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Nearsightedness

Outcome Measures

Primary Outcomes (1)

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

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

  1-month

Study Arms (1)

ICL

OTHER

ICL implantation

Device: Implantable Collamer Lens

Interventions

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.

ICL

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carolina Eyecare Physicians, LLC: lead
• Science in Vision: collaborator

Study Sites (1)

Helga Sandoval

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Carolina Eyecare Physicians, LLC

hsandoval@cepmd.com

8438813937

Study Officials

• Kerry Solomon, MD

  Carolina Eyecare Physicians

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects were implanted with the EVO ICL

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: January 29, 2024
• Primary Completion: August 23, 2024
• Study Completion: August 23, 2024
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)