Working… Menu
Trial record 5 of 6 for:    Recruiting, Not yet recruiting, Available Studies | Hydrophthalmos

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03972852
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : July 8, 2019
Information provided by (Responsible Party):
Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz

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.

Condition or disease
Anesthesia Intraocular Pressure Glaucoma, Suspect Pediatric Glaucoma

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Primary Outcome Measures :
  1. Correlation of BIS and IOP [ Time Frame: during ophthalmological examination under general anaesthesia ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   5 Months to 10 Years   (Child)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03972852

Layout table for location contacts
Contact: Nina Pirlich, MD 00496131177175
Contact: Susanne Fischer 004961311771751

Layout table for location information
Johannes Gutenberg - Universität Recruiting
Mainz, Rhineland Palatinate, Germany, 55131
Contact: Studienzentrum    +496131177175      
Principal Investigator: Nina Pirlich, M.D.         
Sponsors and Collaborators
Johannes Gutenberg University Mainz

Layout table for additonal information
Responsible Party: Nina Pirlich, Dr. med., Principle Investigator, Johannes Gutenberg University Mainz Identifier: NCT03972852     History of Changes
Other Study ID Numbers: eyeBIS 1.0
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Ocular Hypertension
Eye Diseases
Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases
Central Nervous System Depressants
Physiological Effects of Drugs