Analysis of informed consents before ocular muscle surgery including children and adults

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014978

Enrollment

120

Registered

2018-08-22

Start date

2018-05-14

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H50

Interventions

Group 1: Patients facing an ocular muscle surgery are interviewed with a questionnaire, especially invented for the study. They are asked about the informed consent, which had taken place right before

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) adult and politically major patients after the informed consent for an ocular muscle surgery at the University of Heidelberg 2) Parents/ legal agents of underage patients after the informed consent for an ocular muscle surgery at the University of Heidelberg

Exclusion criteria

Exclusion criteria: 1) missing consent to the surgery 2) patients with insufficient knowledge of the German language, which circumvents the correct fill in of the questionnaire

Design outcomes

Primary

Measure	Time frame
1) testing the patient's knowledge with regard to the upcoming eye muscle surgery directly after the informed consent 2) analyzing the effect of the informed consent concerning the patient's feelings The aims are determined by the given answers to the questions of the questionnaire. A score of knowledge is generated for every test person. Every right answer correlates to one point, there are 17 possible points to get. There is an exclusively descriptive data analysis for the questions about patient's feelings.	—

Measure

Time frame

1) testing the patient's knowledge with regard to the upcoming eye muscle surgery directly after the informed consent 2) analyzing the effect of the informed consent concerning the patient's feelings The aims are determined by the given answers to the questions of the questionnaire. A score of knowledge is generated for every test person. Every right answer correlates to one point, there are 17 possible points to get. There is an exclusively descriptive data analysis for the questions about patient's feelings.

—

Secondary

Measure	Time frame
1) Assessment of the patient's interest in informing about the upcoming surgery, it's possibilities, risks and possible complications 2) Correlations between patient's knowledge about the upcoming surgery and his/her graduation 3) Correlations between patient's knowledge about the upcoming surgery and his/her medical education and know-how The questioning takes place right after the informed consent. The data are analyzed descriptively. Afterwards, different sub-groups (for example different graduations) are compared to each other.	—

Measure

Time frame

1) Assessment of the patient's interest in informing about the upcoming surgery, it's possibilities, risks and possible complications 2) Correlations between patient's knowledge about the upcoming surgery and his/her graduation 3) Correlations between patient's knowledge about the upcoming surgery and his/her medical education and know-how The questioning takes place right after the informed consent. The data are analyzed descriptively. Afterwards, different sub-groups (for example different graduations) are compared to each other.

—

Countries

Germany

Contacts

Public ContactFlemming Beisse

Schielbehandlung und Neuroophthalmologie Universitäts-Augenklinik

flemming.beisse@med.uni-heidelberg.de062215636625

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026