to study search History

Quality of life after strabismus surgery

Organizational Data

DRKS-ID:
DRKS00033387
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2024-02-06
Last update in DRKS:
2024-04-03
Registration type:
Prospective

Acronym/abbreviation of the study

QUALITAS

URL of the study

No Entry

Brief summary in lay language

The aim of the study presented here is to investigate the health-related quality of life of patients before and after strabismus surgery and to examine which factors could have an influence on this.

Brief summary in scientific language

Assessment of changes in the health-related quality of life of strabismus patients after strabismus surgery using clinical data and questionnaires.

Health condition or problem studied

ICD10:
H50 - Other strabismus
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Patients with strabismus. Patients with strabismus are interviewed before and after the planned strabismus operation using questionnaires. At the same time, the patients' clinical data is recorded.

Endpoints

Primary outcome:
Postoperative quality of life (after 3 months)
Secondary outcome:
Postoperative quality of life (after 5 years)

Study Design

Purpose:
Other
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
Epidemiological study

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
  • Switzerland
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Universitätsaugenklinik Bonn
  • Other UK Bonn, Bürgerhospital und Clementine Kinderhospital gGmbH, UK Essen deutschlandweit
  • Other Praxis Viktoria Bau, UK Köln, MH Hannover, UK Düsseldorf, PIUS-Hospital Oldenburg deutschlandweit
  • Other Universität Basel, Kantonsspital Aarau Schweiz
  • Other UK Eppendorf, UK Tübingen, UK Würzburg, UK Leipzig, UK Jena, Universität Mainz deutschlandweit
  • Other UK Regensburg, UK Freiburg, UK Göttingen, UK Magdeburg, Augenklinikum Bielefeld Rosenhöhe, UK OWL, UK Tübingen, Klinikum der Stadt Ludwigshafen, UK Münster, ViDia Christliche Kliniken Karlsruhe deutschlandweit

Recruitment period and number of participants

Planned study start date:
2024-07-01
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
1000
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
sufficient German language skills

Exclusion Criteria

Lack of German language skills

Addresses

Primary Sponsor

Universitätsaugenklinik Bonn
Prof. Dr. med. Bettina Wabbels
53127 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsaugenklinik Bonn
Dr. med. Elisa Annabelle Mahler
Ernst-Abbe-Straße 2
53127 Bonn
Germany
Telephone:
0228 / 287 - 15505
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsaugenklinik Bonn
Ernst-Abbe-Straße 2
53127 Bonn
Germany
Telephone:
0228 / 287 - 15505
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsaugenklinik Bonn
Prof. Dr. med. Bettina Wabbels
Ernst-Abbe-Straße 2
53127 Bonn
Germany
Telephone:
+49/ 228/287 - 15612
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universitätsaugenklinik Bonn
Ernst-Abbe-Straße 2
53127 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission Medizinische Fakultät Bonn
Venusberg Campus 1
53127 Bonn
Germany
Telephone:
+49-228-28751562
Fax:
No Entry
Contact per E-Mail
URL:
http://ethik.meb.uni-bonn.de

Vote of leading Ethics Committee

Date of ethics committee application:
2023-09-18
Ethics committee number:
316/23-EP
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-11-20

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
Implementing strabismus-specific psychosocial questionnaires in everyday clinical practice: mental health and quality of life in the context of strabismus surgery
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry