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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030002 S027/ PAS001 |
| Date Original Protocol Accepted |
05/20/2013
|
| Date Current Protocol Accepted |
02/09/2016
|
| Study Name |
New Enrollment Study
|
| Device Name |
TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR 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 |
The objective of this post approval safety study is to evaluate the incidence of
IOL vaulting (ie, position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting) of the Trulign Toric IOL following cataract surgery at up to three years post implantation.
This is a prospective, multicenter, open-label, single arm, post approval study at a minimum of 30 and up to 50 clinical sites in the US.
|
| Study Population |
All subjects who meet eligibility criteria will be consecutively offered enrollment
into the trial until a site meets the maximum number, or the study has fulfilled all enrollment requirements. If both eyes of a subject are eligible for enrollment, the first treated eye should be chosen at the discretion of the surgeon after consultation with the subject. All eyes will be treated in accordance with the Trulign Toric IOL labeled indications for use and the Physician Labeling Directions for Use (DFU).
|
| Sample Size |
The study will enroll up to approximately 686 eyes:
A final sample size of 500 eyes is required. Given losses of 10% per year, after three years the remaining proportion would then be 0.93 or 0.729. Given these losses, if 500/0.729 = 686 eyes are enrolled then approximately 500 eyes will be available after three years.
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| Key Study Endpoints |
The study endpoint is the incidence of clinically significant IOL vaulting (ie,
position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting) up to three years post implant.
|
| Follow-up Visits and Length of Follow-up |
Study participants will be followed for 3 years postoperatively.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
442 (698 eyes)
|
| Actual Number of Sites Enrolled |
31
|
| Patient Follow-up Rate |
Study schedule of subject follow-up:
Preoperative Visit – Day -90 to 0
Operative Visit – Day 0
Postoperative Visit 1 – Day 1 - 2
Postoperative Visit 2 – Day 7 - 14
Postoperative Visit 3 – Day 30 - 60
Postoperative Visit 4 – Day 120 - 180
Postoperative Visit 5 – Day 330 - 420
Postoperative Visit 6 – Day 630 - 780
Postoperative Visit 7 – Day 990 – 1,140
|
| Final Safety Findings |
Two of 686 enrolled eyes had clinically significant IOL vault, for an incidence of 0.29% three years after implantation. In addition, 66 eyes underwent prophylactic neodymium: yttrium-aluminum-garnet (Nd:YAG) procedures to prevent capsular contraction syndrome or vaulting problems. No other safety measures were evaluated in this study.
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| Final Effect Findings |
N/A
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| Study Strengths & Weaknesses |
The primary study endpoint was the incidence of clinically significant IOL vaulting (i.e., position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting) up to 3 years post implant.
Strengths: The study addressed reports in the literature that suggested vault was a significant problem with this type of device, but rates were not well understood. This study provides a reasonable estimation of vault rate.
Potential Weaknesses: The investigators did not always provide detailed reports of all suspected cases of vault, which may have led to underreporting.
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| Recommendations for Labeling Changes |
Update the label to describe findings of the post-approval study and risk of vault
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