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OpenTrials
Completed

NCT Number: NCT02310815

ReSure Sealant Post Approval Study

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.

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Key information

Conditions

Adverse Events

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReSure Sealant

Device

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

    Time frame: Post operative days 20 to 40

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

  4. Surgical reintervention

    Time frame: Post operative days 20 to 40

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

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Official study title

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

Acronym: Clinical PAS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 8, 2014
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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