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ReSure Sealant Post Approval Study

ReSure Sealant Post-Approval Study: A Registry Evaluation of ReSure Sealant for Specified Adverse Ocular Events After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02310815
Acronym
Clinical PAS
Enrollment
626
Registered
2014-12-08
Start date
2014-12-31
Completion date
2016-04-30
Last updated
2016-12-05

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

Conditions

Adverse Events

Brief summary

This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events 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
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement

Exclusion criteria

* ReSure Sealant is not applied to the operative eye

Design outcomes

Primary

MeasureTime frameDescription
Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20)Post operative days 20 to 40—
Hypotony (≤ 5 mmHg)Post operative days 20 to 40—
Ocular discomfortPost operative days 20 to 40Ocular Comfort Index score greater than 51.7 or a within-person increase from baseline of greater than 37.8
Surgical reinterventionPost operative days 20 to 40Surgical reintervention for management of a wound leak - Yes or No

Outcome results

None listed

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