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CompletedNCT02310815Clinical PASUpdated Dec 5, 2016

ReSure Sealant Post Approval Study

An observational study in Adverse Events, sponsored by Ocular Therapeutix, Inc.. Completed. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2016-12-05.

Sponsored by Ocular Therapeutix, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
626
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Adverse Events
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In context

Lead sponsor

Ocular Therapeutix, Inc. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Browse Ocular Therapeutix, Inc. studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated with ReSure Sealant following cataract surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • ReSure Sealant is not applied to the operative eye
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
626 participants (actual)
Patient registry
No

Interventions

  • DeviceReSure Sealant
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What researchers measure

Primary outcomes

  1. Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20)

    Time frame: Post operative days 20 to 40

  2. Hypotony (≤ 5 mmHg)

    Time frame: Post operative days 20 to 40

  3. Ocular discomfort

    Ocular Comfort Index score greater than 51.7 or a within-person increase from baseline of greater than 37.8

    Time frame: Post operative days 20 to 40

  4. Surgical reintervention

    Surgical reintervention for management of a wound leak - Yes or No

    Time frame: Post operative days 20 to 40

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Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2014, a primary completion of Feb 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2014
First posted
Dec 8, 2014
Start
Dec 2014
Primary completionActual
Feb 2016
CompletionActual
Apr 2016
Last update
Dec 5, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02310815
Lead sponsor
Ocular Therapeutix, Inc.
Responsible party
Sponsor
First posted
Dec 8, 2014
Start date
Dec 2014
Primary completion
Feb 2016
Completion
Apr 2016
Last update
Dec 5, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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