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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03972852

Acronym

eyeBIS

Enrollment

120

Registered

2019-06-04

Start date

2019-06-01

Completion date

2025-12-28

Last updated

2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Glaucoma, Suspect, Intraocular Pressure, Pediatric Glaucoma

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Months to 10 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Correlation of the corneal thickness and the intraocular pressure	1 day	Regression

Countries

Germany

Outcome results