Establishment of an Anaesthetic Protocol for Examinations for Children With Glaucoma or Suspected Glaucoma
eyeBIS
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2025
CompletedJanuary 2, 2026
December 1, 2025
3 years
May 31, 2019
December 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation of depth of anesthesia an intraocular pressure
The primary outcome measure is the association between intraocular pressure and bispectral index.
1 day
Secondary Outcomes (3)
Bland Altmann Correlation of Applanation tonometry and rebound tonometry
1 day
Normal range of pediatric intraocular pressure
1 day
Correlation of the corneal thickness and the intraocular pressure
1 day
Eligibility Criteria
Children with glaucoma or suspected glaucoma for ophthalmological examination or surgery
You may qualify if:
- 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
You may not qualify if:
- Contraindication for a laryngeal mask airway
- Known allergy to propofol or remifentanil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johannes Gutenberg - Universität
Mainz, Rhineland-Palatinate, 55131, Germany
Related Publications (1)
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.
PMID: 34610927DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
May 31, 2019
First Posted
June 4, 2019
Study Start
June 1, 2019
Primary Completion
May 30, 2022
Study Completion
December 28, 2025
Last Updated
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share