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CompletedNCT03972852eyeBISUpdated Jan 2, 2026

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

An observational study in Anesthesia, Intraocular Pressure and Glaucoma, Suspect, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Open to participants aged 5 Months to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Johannes Gutenberg University Mainz · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
5 Months to 10 Years
Sex
All
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Study 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.

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Conditions studied

  • Anesthesia
  • Intraocular Pressure
  • Glaucoma, Suspect
  • Pediatric Glaucoma
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In context

Ocular Hypertension

649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.

This study's enrollment of 120 is below the median of 142 across 98 observational studies indexed under Ocular Hypertension.

Browse Ocular Hypertension studies →

Lead sponsor

Johannes Gutenberg University Mainz is the lead sponsor of 153 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Months to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children with glaucoma or suspected glaucoma for ophthalmological examination or surgery

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

Exclusion Criteria:

  • Contraindication for a laryngeal mask airway
  • Known allergy to propofol or remifentanil
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Correlation of depth of anesthesia an intraocular pressure

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

    Time frame: 1 day

Secondary outcomes

  1. Bland Altmann Correlation of Applanation tonometry and rebound tonometry

    Comparison of two different examination tools

    Time frame: 1 day

  2. Normal range of pediatric intraocular pressure

    Defining the normal range of pediatric intraocular pressure

    Time frame: 1 day

  3. Correlation of the corneal thickness and the intraocular pressure

    Regression

    Time frame: 1 day

07

Study locations

1 site
  • Johannes Gutenberg - Universität
    Mainz, Rhineland-Palatinate 55131, Germany
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References and documents

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. PubMed 34610927 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03972852
Lead sponsor
Johannes Gutenberg University Mainz
Responsible party
Nina Pirlich, Dr. med. (Principle Investigator, Johannes Gutenberg University Mainz) — Principal investigator
First posted
Jun 4, 2019
Start date
Jun 1, 2019
Primary completion
May 30, 2022
Completion
Dec 28, 2025
Last update
Jan 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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