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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030028 / PAS001 |
| Date Original Protocol Accepted |
09/10/2004
|
| Date Current Protocol Accepted |
11/10/2011
|
| Study Name |
Long Term
|
| Device Name |
ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Retrospective and Prospective Cohort Study
|
| Study Population |
704 subjects will be evaluated, additional subjects are needed to compensate the lost to follow-up patients
|
| Sample Size |
704 subjects. Participating sites will be determined by the number of patients available.
|
| Key Study Endpoints |
Primary endpoint: Retinal Detachment;
Secondly: device related adverse events such as:
1. Retinal detachment
2. Cataract formation
3. Corneal decompensation
4. Chronic uveitis
5. Persistent (>3 months) elevated intraocular pressure requiring medication, and
6. Secondary surgical intervention (e.g., lens exchange and explants).
|
| Follow-up Visits and Length of Follow-up |
5 years
Annually postoperative
|
| Interim or Final Data Summary |
| Interim Results |
The latest reports prior to study termination show the following advesres events: The highest rates at all visits were for glare/halos (approx 10 15 % at all visits), lens reposition (approx 1 2%), lens dislocation requiring reattachment (approx 0.5 - 1.5%), and "other eye disease" (approx 1 - 2 % at most visits). All other categories generally are reported in <1% of patients.
|
| Actual Number of Patients Enrolled |
383 subjects / 706 eyes
|
| Actual Number of Sites Enrolled |
A total of 37 doctors participated in the PAS
|
| Patient Follow-up Rate |
Most data (362 out of 383 subjects) were collected retrospectively. Among the 383 enrolled subjects, the proportion of patients who had clinical visits at one year, two years, three years, and four years post-operatively were 94.5%, 59.85%, 38.6%, and 32.6% respectively. All subjects (100%) had follow-up data at five years post-operative.
|
| Final Safety Findings |
The primary endpoint for this study is the rate of retinal detachment following lens implantation. This PAS study observed four events of retinal detachment out of 706 eyes. The event rate was 0.57%, which is less than the expected rate of retinal detachment of 2.4% based on a previous literature.
Secondary Endpoints: Rates of corneal decompensation, chronic uvetitis, and persistent elevated intraocular pressure observed in the PAS were relatively consistent with the controlled clinical trial (PMA P030028). Rates of cataract formation (12.04% vs. 0.25%) and surgical intervention (6.80% vs. 2.37%) were higher in the PAS than in the controlled clinical trial (PMA P030028).
|
| Final Effect Findings |
N/A
|
| Study Strengths & Weaknesses |
Strengths: The study involved formal hypotheses testing and it met its primary endpoint at 60 months. Weaknesses: A majority of the study population (361 out of 383 subjects) was consented after 5 years post-operation. For these patients, the safety endpoints were collected retrospectively from medical
records. Because of the retrospective nature, the study was subject to selection bias, misclassification bias, and confounding. Many patients had missing data at the two, three, and four year data points, and the
rates of adverse events including retinal detachment may be underestimated. Moreover, the causes of the
adverse events were often difficult to assess.
|
| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the 5-year long term results from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow up visits etc.), results and study strengths and limitations.
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