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| General |
| Study Status |
Redesigned/Replaced Study |
Application Number /
Requirement Number |
P130004 / PAS001 |
| Date Original Protocol Accepted |
01/08/2014
|
| Date Current Protocol Accepted |
05/05/2020
|
| Study Name |
Device Exposure Registry Study
|
| Device Name |
RESURE SEALANT
|
| General Study Protocol Parameters |
| Study Design |
Retrospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
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| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this study is to collect post-approval data relative to the incidence of endophthalmitis (within 30 days) for cataract surgery patients treated with the ReSure Sealant when used by a broad group of physicians under commercial use conditions.
This study is designed as a retrospective, multicenter, observational, single- arm post-approval registry study that will include up to 100 US centers and will enroll at least 4857 patients treated with ReSure Sealant.
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| Study Population |
The study population is defined as all patients who receive at least one application of the ReSure Sealant on the operative eye in 2014 or 2015 (up to October 2015).
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| Sample Size |
A sample of 4857 patients provides approximately 82% power (alpha = 0.05) to detect a difference (P1 – P0) of -0.0020, using a one-sided binomial test, where P0 is the proportion of endophthalmitis within 30 days under the null hypothesis (0.0040) and P1 is the proportion of endophthalmitis within 30 days under the alternative hypothesis (0.0020).
The results assume that the population proportion under the null hypothesis is 0.0040.
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| Key Study Endpoints |
The primary endpoint will be the occurrence of endophthalmitis (based on
the ‘specific’ definition) within 30 days (±10 days) of the cataract procedure.
Endophthalmitis is defined (i.e., sensitive definition) to have occurred if at least one of the ICD-9-CM or ICD-10-CM codes listed belowhas been reported.
Endophthalmitis is defined (i.e., specific definition) to have occurred if at least one of the ICD-9-CM or ICD-10-CM codes listed below has been reported and at least one of the CPT-4/HCPCS procedure codes listed below has been reported.
ICD-9-CM Codes:
360.0 – purulent endophthalmitis
360.00 – unspecified purulent endophthalmitis
360.01 – acute endophthalmitis
360.02 – panophthalmitis
360.03 – chronic endophthalmitis
360.04 – vitreous abscess
364.03 – secondary iridocycitis, infectious
CPT-4 / HCPCS Procedure Codes:
CPT-4: 66030 – injection of medication in anterior chamber
CPT-4: 67005/67010 – anterior vitrectomy
CPT-4: 67028 – intravitreal injection of pharmacologic agent
CPT-4: 67036 – pars plana vitrectomy
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| Follow-up Visits and Length of Follow-up |
As a retrospective study, there is technically no follow-up. The study is designed primarily to ascertain if Medicare patients treated with ReSure Sealant were diagnosed with endophthalmitis within 30 days of cataract surgery. Patients from the Clinical PAS will be pooled into this study with the outcome reported through site/investigator record review.
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