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

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

• Registration Number: NCT03972852
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study Start: 2019-06-01
• Study First Posted: 2019-06-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-27
• Primary Completion: 2021-12
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Johannes Gutenberg - Universität; 🇩🇪 Mainz, Rhineland Palatinate, Germany