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NCT02563028 · ClinicalTrials.gov registry record · NA

A Novel Method for Capturing the Visual Evoked Potential During Spine Surgery Under Total Intravenous Anesthesia

A NA study, sponsored by Hospital for Special Surgery, New York.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT02563028 is a NA study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 20 participants.

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The verdict

NCT02563028, a NA study, has completed, sponsored by Hospital for Special Surgery, New York.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

Spine surgery in the prone position (which involves lying face down) is associated with various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent blindness. Known risk factors include low blood count (anemia) and long surgical times in the prone position under general anesthesia. While blindness is a rare outcome of this surgery, it is devastating and incompletely prevented by controlling known risk factors. Thus, improved monitoring and detection of visual injury during surgery is necessary. The purpose of this study is to determine whether a novel, non-invasive monitoring device can reliably record visual responses during spine surgery. The first phase of this study is completed and involved patients undergoing microdiscectomy surgery. The second phase of this study involves patients undergoing single-level lumbar spine decompression/fusion surgery.

Interventions

  • DEVICE SightSaver Visual Stimulator

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2015-10
Est. Completion 2016-10
Phase NA

What the Registry Record Tells You About NCT02563028

The ClinicalTrials.gov registry entry for NCT02563028 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which SightSaver Visual Stimulator is the first listed.

NCT02563028 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02563028 about?

NCT02563028 is a clinical study titled "A Novel Method for Capturing the Visual Evoked Potential During Spine Surgery Under Total Intravenous Anesthesia". Spine surgery in the prone position (which involves lying face down) is associated with various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent blindness. Known risk factors include low blood count (anemia) and long surgical times in the prone position under gene...

What is the current status of trial NCT02563028?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2015-10. Estimated completion is 2016-10.

What interventions are being tested in trial NCT02563028?

The interventions under investigation include: SightSaver Visual Stimulator (DEVICE).

Who is sponsoring clinical trial NCT02563028?

This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.