Vault Evaluation After ICL Implantation

C

Carolina Eyecare Physicians, LLC

Status and phase

Not yet enrolling
Phase 4

Conditions

Nearsightedness

Treatments

Device: Implantable Collamer Lens

Study type

Interventional

Funder types

Other

Identifiers

NCT06229119
CEP 23-003

Details and patient eligibility

About

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.

Enrollment

33 estimated patients

Sex

All

Ages

21 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

ICL
Other group
Description:
ICL implantation
Treatment:
Device: Implantable Collamer Lens

Trial contacts and locations

1

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Central trial contact

Helga Sandoval

Data sourced from clinicaltrials.gov

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