N/A
N=410
Post-Market Evaluation of the EVO ICL
Myopia · Myopic Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT05538754 ↗Enrolled (actual)
410
Serious AEs
0.5%
Results posted
Dec 2024
Primary outcome: Primary: Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg — 15 Eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EVO ICL (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Staar Surgical Company
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg |
15 | — |
| PRIMARY Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG |
4 | — |
| SECONDARY Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg |
16 | — |
| SECONDARY Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG |
6 | — |
Summary
The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).
Eligibility Criteria
Inclusion Criteria
- Moderate to high myopia correctable with available EVO ICL powers.
- Moderate to high myopic with astigmatism correctable with available EVO ICL powers.
- Stable refractive history within 0.50 D cylinder for 1 year prior to implantation.
- Stable refractive history within 0.50 D for spherical equivalent 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
- Ocular hypertension or glaucoma.
- Insulin dependent diabetes or diabetic retinopathy.
- History of previous ocular surgery.
- Monocular.
- Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05538754). 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.