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eyeBIS: Establishment of an Anaesthetic Protocol for Examinations for Children With Glaucoma or Suspected Glaucoma

Sponsor
Johannes Gutenberg University Mainz (Other)
Overall Status
Recruiting
CT.gov ID
NCT03972852
Collaborator
(none)
120
Enrollment
1
Location
34
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Correct measurement of the intraocular pressure of children with glaucoma or suspected glaucoma is essential for diagnosis and therapy.

Despite new non-invasive measurement methods most of the children are uncooperative during the ophthalmological examination. Therefore examination under anaesthesia is needed.

A lot of perioperative factors influence the measurement of intraocular pressure.

Established and safe anaesthetic regimes have been modified regarding these factors. Aim of the study is to evaluate, if a standardized anaesthetic protocol generates reliable and reproducible measured values.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Establishment of an Anaesthetic Protocol for Examinations Under Anaesthesia for Children With Glaucoma or Suspected Glaucoma - Correlation of Bispectral Index (BIS) and Intraocular Pressure (IOP)
    Actual Study Start Date :
    Jun 1, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Apr 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of depth of anesthesia an intraocular pressure [1 day]

      The primary outcome measure is the association between intraocular pressure and bispectral index.

    Secondary Outcome Measures

    1. Bland Altmann Correlation of Applanation tonometry and rebound tonometry [1 day]

      Comparison of two different examination tools

    2. Normal range of pediatric intraocular pressure [1 day]

      Defining the normal range of pediatric intraocular pressure

    3. Correlation of the corneal thickness and the intraocular pressure [1 day]

      Regression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Months to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Indication for a general anesthesia (laryngeal mask) and ophthalmological examination and probably surgery

    • Children with glaucoma or suspected glaucoma

    • ASA classification I-III

    • written informed consent of the legal representatives

    Exclusion Criteria:

    • Contraindication for a laryngeal mask airway

    • Known allergy to propofol or remifentanil

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johannes Gutenberg - Universität Mainz Rhineland Palatinate Germany 55131

    Sponsors and Collaborators

    • Johannes Gutenberg University Mainz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nina Pirlich, Dr. med., Principle Investigator, Johannes Gutenberg University Mainz
    ClinicalTrials.gov Identifier:
    NCT03972852
    Other Study ID Numbers:
    • eyeBIS 1.0
    First Posted:
    Jun 4, 2019
    Last Update Posted:
    Aug 27, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glaucoma
    Ocular Hypertension

    Study Results

    No Results Posted as of Aug 27, 2021