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OpenTrials
Completed

NCT Number: NCT03972852

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

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.

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Key information

Conditions

Anesthesia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Abnormalities Eye Diseases Glaucoma Glaucoma, Open-Angle Glaucoma, Suspect Hydrophthalmos Infant, Newborn, Diseases Intraocular Pressure Ocular Hypertension Pediatric Glaucoma

Age range

5 month–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johannes Gutenberg - Universität

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation of depth of anesthesia an intraocular pressure

    Time frame: 1 day

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

Secondary outcomes

  1. Bland Altmann Correlation of Applanation tonometry and rebound tonometry

    Time frame: 1 day

    Comparison of two different examination tools

  2. Normal range of pediatric intraocular pressure

    Time frame: 1 day

    Defining the normal range of pediatric intraocular pressure

  3. Correlation of the corneal thickness and the intraocular pressure

    Time frame: 1 day

    Regression

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study 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)

Acronym: eyeBIS

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Jun 4, 2019
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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