ReSure Sealant Pivotal Study

Ocular Therapeutix, Inc.488 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

488

Conditions

Cataract Surgery Incision Leak

Interventions

ReSure SealantDEVICE

Comparison of ReSure Sealant to suture(s)

SuturesPROCEDURE

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Locations (1)

Levenson Eye Associates

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

Foreign Body Sensation

Time frame: Days 1-28

Best corrected visual acuity

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

Time frame: Day 1

Best corrected visual acuity

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

Time frame: Day 28

Data from ClinicalTrials.gov

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