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OpenTrials
Completed

NCT Number: NCT01498224

ReSure Sealant Pivotal Study

This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.

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Key information

Conditions

Cataract Surgery Incision Leak

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

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 cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens
  • Subject must be 22 years of age or older

Exclusion criteria

  • Any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment
  • Previous corneal or retinal surgery or planned multiple procedures during cataract surgery.

Treatment and study plan

ReSure Sealant

Device

Comparison of ReSure Sealant to suture(s)

Sutures

Procedure

Primary outcomes

  1. Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery.

    Time frame: Days 1-28

Secondary outcomes

  1. Foreign Body Sensation

    Time frame: Days 1-28

  2. Best corrected visual acuity

    Time frame: Day 1

    Best corrected visual acuity worse than 20/40 at day 1

  3. Best corrected visual acuity

    Time frame: Day 28

    Best corrected visual acuity worse than 20/40 at 28 days

Other outcomes

  1. Presence of ReSure Sealant or suture(s)

    Time frame: Day 28

    Presence of ReSure Sealant or suture(s)at every follow-up visit

  2. Presence of blue colorant in ReSure Sealant

    Time frame: Day 28

    Presence of blue colorant in ReSure Sealant at every follow-up visit

  3. Device ease of use

    Time frame: Day 0

    Device ease of use during application

  4. Corneal edema at 1 day

    Time frame: Day 1

    Corneal edema at 1 day (moderate to severe stromal edema)

  5. Anterior chamber inflammation

    Time frame: Day 1

    Anterior chamber inflammation (defined as greater than or equal to grade 2+ anterior chamber cells) at day 1

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2011
Registry last updated
Dec 12, 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.