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OTX-14-002: Device Exposure Registry

Device Exposure Registry: A Post-Approval Observational Registry of ReSure Sealant to Track the Incidence of Endophthalmitis After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02309736
Enrollment
0
Registered
2014-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endophthalmitis

Brief summary

The objective of the study is to collect post-approval data relative to the incidence of endophthalmitis for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions

Interventions

DEVICEReSure Sealant

Sponsors

Ocular Therapeutix, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

All patients that receive at least one application of the ReSure Sealant on the operative eye following cataract surgery will be enrolled.

Design outcomes

Primary

MeasureTime frame
Occurrence of endophthalmitisDay 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026