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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Intraocular Pressure; Anesthesia; Glaucoma, Suspect; Pediatric Glaucoma

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Nina Pirlich, MD; Phone Number: 00496131177175; Email: pirlich@uni-mainz.de
• Study Contact Backup: Name: Susanne Fischer; Phone Number: 004961311771751; Email: susanne.fischer@unimedizin.mainz.de

Study Locations

• Germany
  • Rhineland Palatinate
    • Mainz, Rhineland Palatinate, Germany, 55131
      • Recruiting
      • Johannes Gutenberg - Universität
      • Contact: Studienzentrum; Phone Number: +496131177175
      • Principal Investigator: Nina Pirlich, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with glaucoma or suspected glaucoma for ophthalmological examination or surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of depth of anesthesia an intraocular pressure	The primary outcome measure is the association between intraocular pressure and bispectral index.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bland Altmann Correlation of Applanation tonometry and rebound tonometry	Comparison of two different examination tools	1 day
Normal range of pediatric intraocular pressure	Defining the normal range of pediatric intraocular pressure	1 day
Correlation of the corneal thickness and the intraocular pressure	Regression	1 day

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Publications and helpful links

General Publications

• Pirlich N, Grehn F, Mohnke K, Maucher K, Schuster A, Wittenmeier E, Schmidtmann I, Hoffmann EM. Anaesthetic protocol for paediatric glaucoma examinations: the prospective EyeBIS Study protocol. BMJ Open. 2021 Oct 5;11(10):e045906. doi: 10.1136/bmjopen-2020-045906.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: eyeBIS 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No