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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030016 / PAS002 |
| Date Original Protocol Accepted |
12/22/2005
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| Date Current Protocol Accepted |
12/22/2005
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| Study Name |
Follow-up Study
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| Device Name |
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
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| 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 is a a prospective cohort to continue follow-up of the original PMA Cohort of eyes.
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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 |
526 eyes (294 subjects)
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| Key Study Endpoints |
Safety Endpoints: Specular microscopy (Endothelial Cell Density count), Secondary ICL Related Surgical Procedures (ICL Removal/Cataract Extraction, ICL Replacement, ICL Repositioning),
Crystalline lens evaluation (Lens Opacity), Complications/Adverse Reactions, Intraocular Pressure (IOP) change, Biomicroscopy, Gonioscopy. Effectiveness Endpoints: Best Spectacle, Corrected Visual Acuity (BSCVA) over time, Best Spectacle Corrected Visual Acuity (BSCVA) in Patients with Preop BSCVA 20/20 or Better, Comparison of Preoperative BSCVA to 5 Year Postoperative BSCVA, Change in BSCVA, Uncorrected Visual Acuity (UCVA) - Distance, Manifest Refraction Spherical Equivalent (MRSE)
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| Follow-up Visits and Length of Follow-up |
6, 12, 18, 24, 36, 48, and 60 months
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| Interim or Final Data Summary |
| Interim Results |
Study Final Report received and it is still under FDA Review. Some results: The cell loss between baseline and the three -month visit was 2.2% and between three - month and one- year visit was 0.8%. Over the following two consecutive years, the rate of cell loss appeared to increase, however very slightly, from 2.2% between one and two years postoperatively to 2.9% between two and three years postoperatively. After the three year period, cell loss declined to -2.6% between 3 and 4 years and -2.1% between 4 and 5 years.
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| Actual Number of Patients Enrolled |
294
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| Actual Number of Sites Enrolled |
14
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| Patient Follow-up Rate |
65.3%
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| Final Safety Findings |
Percent change of Endothelial cell loss from baseline to 3 years was 8.18% (SD 7.5%); from baseline to 4 years was 10.1% (SD 8.5%); and from baseline to 5 years was 13.9% (SD 8.7%). Endothelial cell loss over time in persons with extremely high myopia is unknown. Other safety findings for adverse events show none exceeding FDA grid except retinal detachment of 0.6% (FDA grid 0.3%), and surgical reintervention of 4.4% (FDA grid 0.8%). However, surgical reinterventions were not shown to have an impact on safety or efficacy.
Other Complications
Postoperatively Intraocular Pressure (IOP)>25 mmHg during follow-up or an increase of >10 mmHg over preoperative took place in 14 cases through 5 years (only 7 persisted at last visit) which is 2.7% of the Visian ICL PMA cohort. Only 2 cases (0.4%) in the entire cohort were diagnosed with ocular hypertension and started on pressure lowering medication. No cases (0.0%) in this study exhibited optic nerve or visual field changes characteristic of glaucoma.
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| Final Effect Findings |
Visual Acuity
The postoperative results demonstrated that the Visian ICL can provide full correction for high myopia up to -15D and only partial correction up to -20D.
UCDVA= Uncorrected Distance Visual Acuity, Snellen
Where emmetropia was the goal (+0.50D) and Pre-op Best Spectacle Corrected Visual Acuity (BSCVA) was better than or equal to 20/20, the rate of UCDVA at first year is 66.5%, third year 59.2% and fifth year 52.7%.
BCDVA= Best Corrected Distance Visual Acuity, Snellen
Eyes with Preoperative BCDVA 20/20 or better, the rate at first year is 95.3%, third year 96.6% and fifth year 96.2%.
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| Study Strengths & Weaknesses |
The study uses the original IDE cohort following study subjects who had already completed two years of follow-up; therefore long-term data (5-years) is available sooner (as opposed to having newly enrolled subjects). This is the only PAS sub-study that collected ECD data. However, the five year follow-up rate of 65.3% is less than optimal. Biases could have been introduced due to lost to follow-up; which, can limit the generalizability of study results.
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| Recommendations for Labeling Changes |
Yes. Update labeling with long-term data (5-year).
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