Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2009-03-31
2010-10-31
Brief Summary
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Detailed Description
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The device provides continuous irrigation into the eye to prevent collapse of the anterior chamber during insertion. Our study will focus on the safety and efficacy of the novel instrument over the current method of insertion (forceps).
FDA has classified the device as Class I, Reserved.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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EndoSaver™ Corneal Endothelium Delivery Instrument
Efficacy of device to maintain function and integrity of corneal endothelial cells during insertion into the eye during keratoplasty.
Eligibility Criteria
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Inclusion Criteria
45 Years
ALL
No
Sponsors
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Wake Forest University
OTHER
Ocular Systems, Inc.
INDUSTRY
Responsible Party
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Ocular Systems, Inc.
Principal Investigators
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Keith A Walter, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Eye Center
Locations
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Wake Forest University Eye Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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Endo33171
Identifier Type: -
Identifier Source: org_study_id
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