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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030016 / PAS001 |
| Date Original Protocol Accepted |
12/22/2005
|
| Date Current Protocol Accepted |
06/08/2012
|
| Study Name |
Adverse Event Study
|
| Device Name |
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective Registry with patients reporting outcomes
|
| Study Population |
The 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 tile spectacle plane; and, with an anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopter for 1 year prior to implantation. The Study includes subjects who are 21-45 years of age with myopia of -3.0 diopters to -20 diopters.
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| Sample Size |
3,000 eyes will be enrolled
2,000 treated eyes needed with 5-year data
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| Key Study Endpoints |
Corneal edema, cataract, chronic uveitis, glaucoma, retinal detachment, second surgery, and other complications assessed by patient questionnaire
|
| Follow-up Visits and Length of Follow-up |
6, 12, 18, 24, 36,48, and 60 months after implantation
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of 2,999 eyes of 1,547 patients were enrolled in the US between April 2006 through October 2013.
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| Actual Number of Sites Enrolled |
1
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| Patient Follow-up Rate |
100% at 6 months, 100% 12 months, 99.9% 18 months, 98.7% 24 months, 97.4% 36 months, 96.5% 48
months, 96.2% at 60 months (2,125 eyes were followed for 5 years).
|
| Final Safety Findings |
Cumulative Adverse Event rates at 60 months (upper 90%CI)
Corneal problems: 0.0% (0.18%)
Cataract: 2.0% (2.65%)
Treated intraocular inflammation: 0.2% (0.51%)
Treated IOP or glaucoma: 0.2% (0.52%)
Retinal detachment surgery: 0.2% (0.41%)
Remove, replace, or reposition ICL: 1.8% (2.42%) Other ocular conditions/complications
Glare: 0.8%
Halo: 1.5%
Dryness: 1.3%
Secondary surgery (SSI) to address residual astigmatism: 0.7%
Patients and eyes with multiple adverse events
Adverse Events Patients Eyes
2 78 114
3 6 8
4 4 4
Total 88 126
Most common adverse event combination: Cataract/Lens removal in 69 patients (104 eyes).
Cumulative adverse events and comparison with premarket study:
Adverse Event Post-Market Pre-market Study
Corneal problems 0.3%, (5/2999) 0%, (0/526)
Cataract development 5.1%, (154/2999) 8.6%, (45/526)
Treated intraocular inflammation 0.5%, (14/2999) 0.0%, (0/526)
Treated IOP or glaucoma 1.6%, (47/2999) 1.3%, (7/526)
Retinal Detachment Surgery 0.4%, (13/2999) 0.6%, (3/526)
Remove, replace or reposition ICL 4.2%, (126/2999) 4.3%, (23/526)
Glare 2.6%, (66/2527) 9.6%, (34/351)
Halos 5.6%, (142/2527) 11.5%, (40/350)
SSI for residual astigmatism 76/2527 (3.0%) 21/526 (4.0%)
Note: Data at 60 months after surgery for Post-Market, and at =60 months after surgery for Premarket)
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| Final Effect Findings |
This study was required for safety endpoints.
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| Study Strengths & Weaknesses |
Strengths:
Sponsor have enrolled the required sample size and completed the follow-up ahead of schedule. Follow-up rate was higher than 96.2% at 60 months. Therefore, sample size at the end of the follow-up exceeded the minimum number required for analysis.
Data quality control showed 91.4% “no adverse event” agreement in a random sample of study data. A comparison with the premarket data showed comparable event rates in Corneal problems, treated intraocular inflammation, treated IOP or glaucoma, retinal detachment surgery, remove, replace or reposition ICL and secondary surgery to address residual astigmatism. However, slightly lower adverse event rates for cataract development, glare and halos were found in the post-approval study.
Weaknesses:
No concomitant comparator group was included. The study was designed to provide descriptive estimates of the rates for the safety endpoints of interest.
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| Recommendations for Labeling Changes |
No label update recommended because although some results of the PAS show lower incidence rates than in premarket, the differences can be explained by differences in data collection methods. For example, in the premarket study the investigators reported changes in lens opacity based on slit lamp observation at each visit, while survey questionnaires were used in the post-approval study, which may capture the practice of physicians who are less likely to report clinically insignificant changes.
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