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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P120023 / PAS001 |
| Study Name |
Continuation Study
|
| Device Name |
KAMRA INLAY
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this study is to evaluate the safety of the AcuFocus¢â ACI 7000PDT corneal inlay implanted intrastromally in presbyopes and the effectiveness of the inlay for improvement of near vision.
|
| Study Population |
Presbyopic subjects needing a magnitude of 1.00D to 2.50D of reading add will be enrolled. Subjects must be natural emmetropes and have a preoperative spherical equivalent of plano defined as +0.50D to -0.75D with no more than 0.75D of refractive cylinder as determined by cycloplegic refraction. Eligible subjects must be greater than or equal to 45 years and less than or equal to 60 years of age.
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| Sample Size |
This will be a prospective multicenter clinical trial in which 400 consecutive eyes of 400 patients will be implanted with the ACI 7000PDT and followed with post-operative visits over a 36 month period at a maximum of 20 clinical sites. Enrollment of the study population will be phased, such that 75 eyes will be enrolled initially. Following review of 3-month postoperative data from the first 75 eyes having undergone ACI implantation, an interim report will be submitted requesting expansion to the full study population- an additional 325 eyes.
|
| Key Study Endpoints |
Postoperatively, subjects will undergo complete ophthalmic
examinations at regular intervals to evaluate safety and effectiveness of the ACI in improving near vision.
-Improvement in uncorrected near visual acuity (40cm/16in.) at 12 months. 75% of eyes should achieve uncorrected near
visual acuity of 20/40 or better.
-Subjective improvement in near vision as measured by
subject satisfaction questionnaire.
Primary Effectiveness Endpoint
The percentage of eyes with a UCNVA of 20/40 or better (success rate) will be calculated at each postoperative visit for near ETDRS visual acuity. The 95% confidence intervals of the success rates will be calculated based on the exact binomial distribution. The 95% confidence interval at 12-months will be used to compare with the target success rate of 75%. The lower limit of the confidence interval must be 75% or greater in order to claim effectiveness of the device.
Logistic regression analyses will be used to examine the possible effects of investigator sites, age, flap thickness, and other clinical parameters identified by clinicians prior to the analyses. The success rates will be stratified by the significant factors identified by the logistic regression.
Secondary Effectiveness Outcome
The secondary effectiveness endpoint of subjective improvement in near vision as measured by subject satisfaction questionnaire will be assessed when the primary effectiveness endpoint has been achieved. Change in subject satisfaction from baseline, and the reduction in spectacle dependence for near tasks will be summarized by descriptive statistics such as mean and frequency. The corresponding 95% confidence intervals for mean and frequency will be calculated.
|
| Follow-up Visits and Length of Follow-up |
Postoperative follow-up through 36 months on all study patients will be completed.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
271
|
| Actual Number of Sites Enrolled |
19 (13 US, 6 OUS)
|
| Patient Follow-up Rate |
93.4% (253/271)
|
| Final Safety Findings |
The safety cohort consists of 269 subjects at 48 months and 253 subjects at 60 months. The primary safety outcome of persistent
BCDVA loss of two or more lines at two or more consecutive visits was 0.7% (2/269) at 48 months and 0.8% (2/253) at 60 months, both
of which were below the protocol-specified target of less than 5%. The two cases of persistent loss of BCDVA at Months 48 and 60
(61118 and 86120) were attributed to lenticular changes.
|
| Final Effect Findings |
The primary effectiveness parameter specified in the protocol was improvement in uncorrected near visual acuity (UCNVA) at Month
12, with a target of at least 75% attaining monocular 20/40 or better UCNVA. The effectiveness cohort consisted of 267 subjects at 48
months and 252 subjects at 60 months. For monocular UCNVA of implanted eyes, 89.1% (238/267) of eyes had UCNVA of 20/40 or
better at Month 48 and 215/252 (85.3%) at Month 60. These results are consistent with the 87.1% (363/417) reported at Month 36. For
changes from baseline UCNVA in the implanted eye, gains of greater than or equal to 2 lines were sustained in 75% or more of the eyes
through 60 months; gains of greater than 3 lines were sustained in approximately half of the eyes. Looking specifically at gains in
UCNVA of 2 lines or greater, the reported proportions are 78.2% (326/417) at Month 36, 75.7% (202/267) at Month 48 and 189/252 (75.0%) at Month 60.
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| Recommendations for Labeling Changes |
Yes
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