AnesthesiaeyeBISNCT03972852
Establishment of an Anaesthetic Protocol for Examinations for Children With Glaucoma or Suspected Glaucoma
An observational study of Anesthesia and Intraocular Pressure, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Intraocular Pressure, Glaucoma, Suspect
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2019to 28 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with glaucoma or suspected glaucoma for ophthalmological examination or surgery
Who may be able to join
- 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
Who cannot join
- Contraindication for a laryngeal mask airway
- Known allergy to propofol or remifentanil
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johannes Gutenberg - Universität
Mainz, Rhineland-Palatinate, 55131
About this study
Official 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)
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.
- Medical subject headings
- Ocular Hypertension, Hydrophthalmos
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of depth of anesthesia an intraocular pressure
The primary outcome measure is the association between intraocular pressure and bispectral index.
Measured: 1 day
Secondary outcomes (3)
Bland Altmann Correlation of Applanation tonometry and rebound tonometry
Comparison of two different examination tools
Measured: 1 day
Normal range of pediatric intraocular pressure
Defining the normal range of pediatric intraocular pressure
Measured: 1 day
Correlation of the corneal thickness and the intraocular pressure
Regression
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jun 2019
- Primary completion30 May 2022
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972852
- Sponsor's protocol ID
- eyeBIS 1.0
- Acronym
- eyeBIS
- Status last verified
- Dec 2025
- First submitted
- 31 May 2019
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03972852
- Acronym / sponsor ID
- eyeBIS / eyeBIS 1.0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with glaucoma or suspected glaucoma for ophthalmological examination or surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindication for a laryngeal mask airway
- Known allergy to propofol or remifentanil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Bland Altmann Correlation of Applanation tonometry and rebound tonometry
Time frame: 1 day
Normal range of pediatric intraocular pressure
Time frame: 1 day
Correlation of the corneal thickness and the intraocular pressure
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Derived from this study: PubMed 34610927Pirlich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Intraocular Pressure, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of depth of anesthesia an intraocular pressure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03972852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.