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| General |
| Study Status |
Other |
Application Number /
Requirement Number |
P150034 / PAS001 |
| Date Original Protocol Accepted |
12/27/2016
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| Date Current Protocol Accepted |
01/04/2022
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| Study Name |
Post-Approval Study
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| Device Name |
Raindrop Near Vision Inlay
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a new enrollment and continued follow-up of a single-arm, prospective, multicenter study to evaluate the long term safety of the Raindrop® Near Vision Inlay implanted in an emmetropic population (continued follow-up of premarket cohort). All subjects who meet the inclusion criteria will be followed over a 60-month period or 24 months post inlay removal.
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| Study Population |
This is a continuation study of the IDE cohort and continued enrollment of about 75 subjects per month.
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| Sample Size |
Not applicable for this study as this is a continuation study of the IDE cohort.
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| Key Study Endpoints |
1. Preservation of best corrected visual acuity
2. Incidence of secondary surgical interventions
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| Follow-up Visits and Length of Follow-up |
60-months
Follow-ups at 1 day, 1 month, 6 months, 12 months, and 24 months. For subjects that have not had inlay removed then examinations will also occur at 48 months and 60 months.
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| Interim or Final Data Summary |
| Interim Results |
Actual Number of Patients Enrolled: 150 subjects
Actual Number of Sites Enrolled: 4 US sites
Interim Results: This update reflects interim data as of July 24, 2018. Subject enrollment has been completed. The study cohort consisted of 150 subjects at various stages of patient follow-up. The first primary safety endpoint was preservation of best-corrected distance visual acuity (BCDVA). 5.3% [8/150] of subjects experienced a persistent BCDVA loss of 2 lines or more at the last available visit. Regarding the secondary primary safety endpoint of the rate of secondary surgical interventions (SSI) over 60 months postoperatively, 12.7% [19/150] of subjects underwent SSI.
FDA publicly communicated on October 23, 2018, regarding two safety concerns identified from the most recent interim study report: the percentage of subjects with corneal haze, and the percentage of subjects requiring device removal. The rate of central corneal haze of any severity was 42% (63/150) at any time point. The rate of corneal haze at any location and of any severity was 75% (113/150). One patient first developed haze 6 months after removal of the device. Study follow-up is ongoing; however, of the subjects who completed 60 months of follow-up, twenty-two subjects developed their first episode of haze at the 60 month visit. The percentage of patients with two or more lines loss of BCDVA caused by corneal haze (2.0%, 3/150) was greater than what was observed at Month 36.
In this study, 31 subjects (20.7%) were treated with steroids for corneal haze at any time. Of patients who still had the device implanted, 23.7% (29/122) were prescribed steroid eyedrops to treat corneal haze. Of these 29 patients who were treated with steroids, 8 patients were treated for 3 months or more, and an additional 10 patients were being actively treated at the time of the study report or left the study while on active treatment.
Of the 150 patients enrolled in the post-approval study, 35 patients (23.3%) have had their device removed (for haze or other reasons) either during the post-approval study or after they exited the IDE study. In addition, some patients continued to have corneal haze after the device was removed.
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