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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02310815
Other study ID # OTX-13-003
Secondary ID
Status Completed
Phase N/A
First received December 3, 2014
Last updated December 2, 2016
Start date December 2014
Est. completion date April 2016

Study information

Verified date December 2016
Source Ocular Therapeutix, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 626
Est. completion date April 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 22 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
ReSure Sealant


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ocular Therapeutix, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Anterior chamber cells greater than level 1+ persisting at Visit 2 (= Day 20) Post operative days 20 to 40 Yes
Primary Hypotony (= 5 mmHg) Post operative days 20 to 40 Yes
Primary Ocular discomfort Ocular Comfort Index score greater than 51.7 or a within-person increase from baseline of greater than 37.8 Post operative days 20 to 40 Yes
Primary Surgical reintervention Surgical reintervention for management of a wound leak - Yes or No Post operative days 20 to 40 Yes
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