NCT01498224

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 12, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

December 18, 2011

Last Update Submit

December 8, 2016

Conditions

Cataract Surgery Incision Leak

Keywords

Cataract surgery

Outcome Measures

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.

    Days 1-28

Secondary Outcomes (3)

  • Foreign Body Sensation

    Days 1-28

  • Best corrected visual acuity

    Day 1

  • Best corrected visual acuity

    Day 28

Other Outcomes (5)

  • Presence of ReSure Sealant or suture(s)

    Day 28

  • Presence of blue colorant in ReSure Sealant

    Day 28

  • Device ease of use

    Day 0

  • +2 more other outcomes

Study Arms (2)

Suture

ACTIVE COMPARATOR

Suture application

Procedure: Sutures

ReSure Sealant

EXPERIMENTAL

Sealant application

Device: ReSure Sealant

Interventions

ReSure SealantDEVICE

Comparison of ReSure Sealant to suture(s)

ReSure Sealant
SuturesPROCEDURE
Suture

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

Related Links

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2011

First Posted

December 23, 2011

Study Start

December 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 12, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Data is available on FDA website for approved PMA P130004

Locations

US(1)