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| General |
| Study Status |
Other |
Application Number /
Requirement Number |
P150034 / PAS002 |
| Date Original Protocol Accepted |
01/24/2018
|
| Date Current Protocol Accepted |
10/09/2019
|
| Study Name |
Raindrop Near Vision Inlay New Enrollment
|
| Device Name |
Raindrop Near Vision Inlay
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Study Overview:
This post-approval study (PAS) registry is a new enrollment single-arm, prospective, multicenter study to collect postoperative data for up to 5 years and evaluate the long term safety of the Raindrop® Near Vision Inlay in emmetropic patients.
Study Design:
The Study will be conducted in two phases.
Phase One
A questionnaire will be developed to elicit the reason(s) for device explantation, including the effects of visual symptoms. Subject who have previously had the Raindrop inlay removed or are considering having the inlay removed will be recruited for phase one. The questionnaire will be assessed qualitatively through hybrid concept elicitation and cognitive debriefing interviews.
The qualitative assessment will evaluate:
(1) The clarity of the items within the instrument;
(2) How the respondents interpret the item(s);
(3) Ease of completion of the patient-reported outcomes (PROs);
(4) The comprehensiveness of the PROs; and
(5) The appropriateness of the format, response scales, and recall period used in the PROs.
Once the results of phase one are reviewed by FDA, patients will be enrolled in Phase two of the study.
Phase Two
The questionnaire developed in phase one of the study will be administered as a nested component of the post-approval study.
The Phase two PAS will be a prospective, multicenter, single-arm clinical registry consisting of 528 eyes from 528 presbyopic patients with emmetropia (defined as having +1.00 D to -0.50 D manifest spherical equivalent) between the ages of 41 and 65 years, enrolled from up to 30 sites in the United States for unilateral implantation of the Raindrop inlay in the non-dominant eye to ensure that at least 422 patients (assuming an overall attrition rate of 20%) will be available for long-term follow-up at 60 months after implantation.
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| Study Population |
A total of 528 eyes from 528 presbyopic patients 41 to 65 years of age, who have manifest refractive spherical equivalent of (MRSE) +1.00 diopters (D) to -0.50 D with less than or equal to 0.75 D of refractive cylinder, who do not require correction for clear distance vision, but who do require near correction of +1.50 D to +2.50 D of reading add.
Patients must have provided informed consent for the Raindrop inlay implantation, who are capable of comprehending the nature of the study, and who are likely to comply with the visit schedule are to be entered into Phase 2 of the study.
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| Sample Size |
528 eyes /patients are needed to determine the safety of the inlay (co- primary safety endpoints), to provide a statistical power of at least 80% at the one-sided significance level of 0.025, with an assumed attrition rate of 20% over the 60-Month follow-up period.
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| Key Study Endpoints |
Primary Safety Endpoints:
1) Loss of two (2) lines or more of best corrected distance visual acuity (BCDVA) at 60 months after inlay implantation, or 24 months after removal, whichever is longer, is fewer than 5%.
2) Incidence rate of inlay removal secondary surgical interventions will be 10% or less.
Both of the alternative hypotheses should be met in order to determine the safety of the inlay.
Secondary Safety Endpoints:
1) The rate of secondary surgical interventions overall and by type (e.g. exchange); and
2) The rate of adverse events categorized as ocular, device and/or procedure related, unanticipated, or other.
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| Follow-up Visits and Length of Follow-up |
60 months postoperatively or 24-months post-removal, whichever is longer after initial implantation.
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