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Vault Evaluation After ICL Implantation
Phase 4 trial testing Implantable Collamer Lens in Nearsightedness in 20 participants. Completed in 23 August 2024.
| Lead sponsor | Carolina Eyecare Physicians, LLC |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 29 January 2024 |
| Primary completion | 23 August 2024 |
| Estimated completion | 23 August 2024 |
| Sites | 1 location across United States |
Carolina Eyecare Physicians, LLC — full company profile →
Adults 21 to 45, any sex, with Nearsightedness. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference between the predicted vault at the preoperative visit and the actual vault measured at the 1-month visit
| Group | Value | 95% CI |
|---|---|---|
| ICL Implantation Group | 0.170 | ± 0.137 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06229119.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing