Reliability and Reproducibility of Automated Angular Measurement in Strabismus

NCT ID: NCT03596138

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-04
• Study Completion Date: 2019-04-29

Brief Summary

Angular measurement of deviation is an essential element in the clinical evaluation of strabic patients. It is performed by orthoptic methods. However, studies show that the same patient presents a great variability of his angular measurement between 2 consultations, and between 2 observers.

Automated angle measurement is a recent concept that aims to overcome the defects of subjective angle measurement by alternate occlusion test and prismatic bar.

Improvements made by these devices would provide reliable, objective and reproducible measurements of the angle of deviation by increasing the accuracy of strabal angle assessment, improving decision making and surgical follow-up, decreasing inter-examiner variability and variability over time, and facilitating data comparison to improve scientific publication possibilities.

The Gazelab® device is a video-oculograph combined with a laser projection system and an infrared camera. It allows an objective angular evaluation, in non-dissociating physiological conditions, possible even in the absence of binocular vision and allows an analysis of the deviation in all positions.

There is extremely little data in the literature on automated measuring devices. The Gazelab tool is still little known in the strabology discipline and seems to have a number of advantages over other devices. The interest of this examination towards this pathology led the ophthalmology department to use it in the current practice, and since recently it is an act nomenclaturé.

Detailed Description

The objective of this work is to evaluate the reliability and reproducibility of the automated angular measurement by the Gazelab® (ES12/13127) apparatus, compared to the standard gold which is the angular measurement by alternate occlusion test and prismatic bar, in horizontal strabisms (converging and diverging). Indeed in our daily practice the 2 examinations are carried out. To compare with the standard gold which denotes a strong inter-observer variability, the investigator will compare the results of the Gazelab to the alternate occlusion by prism bar (standard gold) 2 times with 2 trained examiners

Conditions

Strabismus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Evaluate the reliability and reproductibility of the automated angular measurement by the Gazelab

Compare the results of the Gazelab to the alternate occlusion by prism bar (standard gold) examiners.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years of age
• Strabic convergent or divergent patients or patients requiring an oculomotor check-up in their follow-up consultation
• Patient giving oral consent to this study

Exclusion Criteria

• Patient with medical follow-up impossible,
• Impossibility to install Gazelab equipment for anatomical reasons of the head (craniostenosis...)
• No ocular fixation.
• Major without freedom under guardianship or trusteeship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre LEBRANCHU, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

CHU Nantes

Nantes, , France

Countries

France

Other Identifiers

RC18_0062

Identifier Type: -

Identifier Source: org_study_id