OTX-14-002: Device Exposure Registry

NCT ID: NCT02309736

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Brief Summary

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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

Detailed Description

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Conditions

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Endophthalmitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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ReSure Sealant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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OTX-14-002

Identifier Type: -

Identifier Source: org_study_id

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