|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030028 / PAS002 |
| Date Original Protocol Accepted |
09/10/2004
|
| Date Current Protocol Accepted |
09/10/2004
|
| Study Name |
ECD Study
|
| 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 & Retrospective Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent & Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective study that extends the follow-up of the premarket study for safety and efficacy of the ARTISAN Myopia lens. Study subjects will be followed out to five year postoperative data as follows:1) Subjects implanted in 2000 and 2001 will be asked to participate in the study extension to acquire all available four and five year data within the next two years (from PMA approval 2004).
|
| Study Population |
As per device indication. The device is indicated for the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less th:in or equal to 2.5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3.2 millimeters; and,- patients with documented stability of refraction for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0.50 diopters. Study population consists of the premarket cohort.
|
| Sample Size |
A total of 503 eyes were implanted during this time period (282 first eyes and 221 second eyes).
|
| Key Study Endpoints |
Data collected will include:* Uncorrected distance visual acuity* Manifest refraction* Best corrected distance visual acuity* lop* Endothelial cell count (images to be read by single reading center)* Complications and adverse events, including but not limited to: Cataract formation, Retinal detachment rates, Comeal decompensation, Chronic uveitis, Persistent elevated lOP requiring medication, Secondary surgical interventions (lens exchanges, explants, etc.)
|
| Follow-up Visits and Length of Follow-up |
These subjects will be asked to return for yearly follow-up until live year data has been acquired for each eye implanted.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Number of eyes available for analysis at enrollment (pre-operative): 1,139
|
| Actual Number of Sites Enrolled |
37 doctors participated at one site.
|
| Patient Follow-up Rate |
Available eyes for analysis post-implantation, compared to baseline (i.e., before implantation):
89.8% at 6 months
90.7% at 1 year
83.9% at 2 years
67.3% at 3 years
42.5% at 4 years
39.0% at 5 years
|
| Final Safety Findings |
Eyes greater than or equal to 30% loss ECD, compared to baseline, among eyes with readable images:
two (1.4%) at 6 months, 1 (0.7%) 1 year, 4 (3.2%) 2 years, 4 (4.5%) at 3 years, 1 (2.6%) at 4 years and none at five years. These percentages were calculated after comparing each one to the earliest available postop reading. When preop data is unavailable does not accurately reflect patient conditions (i.e., the data points at different intervals are weighted differently).
According to the sponsor, after thorough review of all patient files, no adverse events (or serious complications) were reported that may have contributed to the ECD loss.
A comparison of cumulative complications/adverse events during PMA (N = 662) and PAS (N = 702) show the following results:
DESCRIPTION PMA PAS
n (%) n (%)
Cataract 21( 3.17) 11( 1.57)
Glaucoma 0( 0.00) 6( 0.85)
Significant Corneal Problems 20 ( 3.02) 11( 1.57)
Significant Glare 142(21.45) 129(18.38)
Retinal Detachment 4( 0.60) 7( 1.00)
Lens Exchange 9( 1.36) 3( 0.43)
Preventive Lens Repositioning 14( 2.11) 20( 2.85)
Lens Dislocation/Reattachment 5( 0.76) 8( 1.14)
Lens Explant 10( 1.51) 3( 0.43)
Other Eye Disease 58( 8.76) 24( 3.42)
The sponsor presented results from seven published articles. Among these publications, a 10 year retrospective single cohort study in 89 implanted eyes provided complementary clinical information: The mean spherical equivalent (SE) after 10 years was -0.70±1.00 diopters (D; range, -4.00 to 2.00 D), with no significant change in mean SE between 1, 6, and 10 years. At 10 years, 68.8% of all eyes were within 1.0 D of the intended correction. At 10 years, 31.2% (n =
24) gained 1 or more Snellen lines of BCVA and 2.6% (n = 2) lost more than 2 Snellen lines of BCVA; 93.3% reached a BCVA of 20/40 or better, and 82.0% reached a UCVA of 20/40 or better. The mean intraocular pressure remained stable and was 15.5±3.5 mmHg (range, 7-25 mmHg) at
10 years (Nayyirih G. et al. 2007, Ophthalmology; 114:1133-1142).
|
| Final Effect Findings |
Effectiveness is not a part of the post-approval study requirement and therefore it is not reported by the sponsor.
|
| Study Strengths & Weaknesses |
Strengths:
a. Large initial sample size
Weaknesses:
a. No control or comparison group was included.
b. The number of participating subjects reduced considerably during follow-up: The number of eyes with readable images dropped from 504 eyes at 2 years postop to 422 eyes (83.7%) at 3 years in the pre-approval phase. After that, the number of eyes with readable images declined substantially to 204 eyes (40.5%) and 170 eyes (33.7%), at 4 and 5 years respectively as compared to 2 years postop (504 eyes). This sample size reduction increased the likelihood of selection bias: Lost to follow-up subjects tend to have relatively worse safety outcomes, and thus the results of the study may reflect a potential underestimation of the incidence of long-term safety issues related to this device.
|
| Recommendations for Labeling Changes |
Labeling should include a brief description of the study objectives, design, study population, key study endpoints, study visits, length of follow-up, total number of enrolled study sites and subjects, follow-up rate, safety results, and study strengths and weaknesses.
|
