N/A
Completed N=40
Galilei Lens Professional vs. Predicate Devices: a Comparison Study
Source: ClinicalTrials.gov NCT01961089 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Agreement With Predicate Devices in Terms of Agreement 1 — -0.010; -0.023; -0.014; 0.005 Units are mm — p=0.09
Summary
Study question: How does the new GALILEI Lens Professional compare to predicate devices? Study hypothesis: The GALILEI Lens Professional achieves a better precision in the postoperative, calculated target refraction with cataract surgeries than predicate devices, and it is more versatile in the measurable parameters as well as more user-friendly.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement With Predicate Devices in Terms of Agreement 1 |
-0.010; -0.023; -0.014; 0.005; 0.137; 0.052 | 0.09 |
| PRIMARY Agreement With Predicate Devices in Terms of Agreement 2 |
-0.031; -0.033; 0.008 | 0.13 |
| SECONDARY Agreement With Devices of the Same Type in Terms of Repeatability |
0.0018; 0.0010; 0.0008; 0.0040; 0.0082; 0.0259 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- spherical equivalent between -10 D and +10 D
- best-corrected VA of 20/100 or better.
Exclusion Criteria
- strabism
- blepharitis
- nystagmus
- amblyopia
- anisometropia (spherical equivalent > 1D)
- angle closure glaucoma
- seizure disorder
- brain damages
- Down syndrome
- trisomy 13 or 18
- cerebral palsy
- other serious disorders of the eye or central nervous systems
Data sourced from ClinicalTrials.gov (NCT01961089). 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.