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

NCT ID: NCT03972852

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2025-12-28

Brief Summary

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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

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Conditions

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Anesthesia Intraocular Pressure Glaucoma, Suspect Pediatric Glaucoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

5 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Nina Pirlich, Dr. med.

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johannes Gutenberg - Universität

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 34610927 (View on PubMed)

Other Identifiers

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eyeBIS 1.0

Identifier Type: -

Identifier Source: org_study_id

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