N/A
Completed N=654
Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)
Source: ClinicalTrials.gov NCT04283149 ↗Enrolled (actual)
654
Serious AEs
1.9%
Results posted
Jul 2022
Primary outcomePrimary: Number of Primary Eyes Requiring Peripheral Iridotomy (PI) — 0 eyes
Summary
This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Primary Eyes Requiring Peripheral Iridotomy (PI) |
— | — |
| PRIMARY Endothelial Cell Density (ECD) Change in Primary Eyes. |
-2.4 | — |
| PRIMARY Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes. |
— | — |
| PRIMARY Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes. |
— | — |
| PRIMARY Number of Ocular Adverse Events (AEs) in Primary Eyes. |
108 | — |
| SECONDARY Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI) |
— | — |
| SECONDARY Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes. |
-2.26 | — |
| SECONDARY Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes. |
— | — |
| SECONDARY Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes. |
— | — |
| SECONDARY Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes |
203 | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to high myopia or myopic astigmatism correctable with available EVO/EVO+ ICL powers.
- Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation.
- Able and willing to return for scheduled follow-up examinations after surgery.
- Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Insulin-dependent diabetes or diabetic retinopathy.
- History of previous ocular surgery.
- Cataract of any grade.
- Monocular.
- Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04283149). 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.