NCT06229119

CompletedPhase 4

Vault Evaluation After ICL Implantation

Carolina Eyecare Physicians, LLC Source

Carolina Eyecare Physicians, LLC

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CEP 23-003

Study Type

interventional

Actual enrollment (reported)

20

Locations

1 country

Sites

1

Timeline

Study Start

January 29, 2024

Actual (reported)

Primary Completion

August 23, 2024

Actual (reported)

Study Completion

August 23, 2024

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 20 participants
Study completion date: August 23, 2024
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 19, 2024
Actual (reported)
First Posted
January 29, 2024
Actual (reported)
Study Start
January 29, 2024
Actual (reported)
Primary Completion
August 23, 2024
Actual (reported)
Study Completion
August 23, 2024
Actual (reported)
Results Posted
March 4, 2025
Actual (reported)

Last Updated: March 4, 2025
Status Verified: January 2025
Results QC Date: February 25, 2025
Last Update Submitted: February 25, 2025

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 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.

ICL

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years - 45 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Gender: Males and Females.
Age: 21 to 45 years of age

Sponsors & Collaborators

Science in Vision
Othercollaborator
Carolina Eyecare Physicians, LLC
Otherlead

Study Sites (1)

Helga Sandoval

Mt. Pleasant, South Carolina, 29464, United States

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

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

Study Officials

Kerry Solomon, MD
Carolina Eyecare Physicians
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 29, 2024

Study Start

January 29, 2024

Actual (reported)

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Phase 4Unknown

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Echothiophate Iodide for the Prevention of Progression of Myopia

Phase 4Withdrawn

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Preservative-free Topical Anesthetics for Post-PRK Pain

Phase 4Completed

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The Influence of Atropine on Choroidal Thickness

Phase 4Completed

NCT03544827

The Effects of Low Dose Atropine on Choroidal Thickness

Phase 4Completed

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Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision

Phase 4Completed

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.

Contact the study team to confirm eligibility.

Primary Completion

August 23, 2024

Actual (reported)

Study Completion

August 23, 2024

Actual (reported)

Last Updated

March 4, 2025

Results First Posted

March 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06229119
Data provider: ClinicalTrials.gov
Source updated: 2025-03-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:18 UTC

Documents

Study Protocol and Statistical Analysis Plan
ProtocolSAP2023-12-19

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

ICL

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations