Phase 4
Completed N=20
Vault Evaluation After ICL Implantation
Nearsightedness
Source: ClinicalTrials.gov NCT06229119 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Mean Difference Between Predicted and Actual Central Vault at 1-month After ICL Implantation — 0.170 Milimeters
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference Between Predicted and Actual Central Vault at 1-month After ICL Implantation |
0.170 | — |
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.
Data sourced from ClinicalTrials.gov (NCT06229119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.