Vault Evaluation After ICL Implantation

Completed · Phase 4

Conditions studied: Nearsightedness

In brief

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.

Key facts

Study ID

NCT06229119

Run by

Carolina Eyecare Physicians, LLC

People needed

20

Starts

2024-01-29

Expected to finish

2024-08-23

Last updated by the study team

2025-03-04

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Helga Sandoval — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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