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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030016 / PAS003 |
| Date Original Protocol Accepted |
12/22/2005
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| Date Current Protocol Accepted |
12/22/2005
|
| Study Name |
Axial Lengths
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| Device Name |
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This clinical study is a prospective cohort, two-center, non-randomized study. The objective of this clinical investigation is to assess the effect of the STAAR Myopic Implantable Collamer Lens (Visian ICL) on the measurement of axial length of the eye to determine whether the ICL effects this measurement. This analysis is important for future cataract extractions in patients with an ICL so that the correct IOL power is implanted.
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| Study Population |
Study population is as per device indication: This device is indicated for adults 21-45 years of age: * to correct myopia ranging from -3.0 diopters to < - 15.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; * to reduce myopia ranging from greater than -15.0 diopters to - 20.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; and,* with an anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopter for i year prior to implantation.
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| Sample Size |
30 eyes (30 patient)
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| Key Study Endpoints |
Axial length of the eye
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| Follow-up Visits and Length of Follow-up |
baseline & 1 month
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| Interim or Final Data Summary |
| Interim Results |
Study is completed. See Final Results
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| Actual Number of Patients Enrolled |
30
|
| Actual Number of Sites Enrolled |
2
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| Patient Follow-up Rate |
100%
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| Final Safety Findings |
24 of the 30 patients were from Site 1 and 6 patients were from site 2. Eleven were male and 19 female, 29 were Caucasian and one Asian. Safety Summary: No adverse events were observed during the study.
Effectiveness Summary: The ICL power of the lens implanted averaged -10.68D (range -3.50 to -16.00). The pre-op axial length averaged 27.30mm (range 23.69 to 34.32) and the post-op axial length averaged 27.28mm (23.72 to 34.51). The average difference in axial length measurements is -0.02mm (range-0.23 to + 0.19).
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| Study Strengths & Weaknesses |
One of the strenghts is that this was a prospective study. However, the length of follow-up up was just one month post-treatment.
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| Recommendations for Labeling Changes |
Labeling should be updated to include a summary of the post-approval study design, results, and study strengths and limitations.
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