Reliability and Reproducibility of Automated Angular Measurement in Strabismus (FREGMA)

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.

Study Overview

• Status: Completed
• Conditions: Strabismus
• Intervention / Treatment: Other: Evaluate the reliability and reproductibility of the automated angular measurement by the Gazelab

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

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Chu Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Strabismus is a pathology that affects 2 to 4% of the French population. The Ophthalmology Department sees 200 adult patients with strabismus per month. In 6 months it will be easy to include in 30 months 30 patients of convergent strabismus and 30 of divergent strabismus. For patients with eye strain who do not have eye refractive errors the Department of Ophthalmology sees 2000 patients per month, to include these 30 patients in 6 months.

Since this study is a prospective non-interventional research study, the patient may be part of a biomedical research study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-class correlation coefficient	Intra-class correlation coefficient calculated on the 4 measures (2 of each technique) of each patient taken at time 1 by the same assessor.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-class correlation coefficient using measurements	Intra-class correlation coefficient using measurements from each technique between 2 different evaluators at time 1	12 months
Intraclass correlation coefficient using time 1 and time 2 measurements	Intraclass correlation coefficient using time 1 and time 2 measurements with the same investigator	12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Pierre LEBRANCHU, Dr, Chu Nantes

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): April 29, 2019
• Study Completion (Actual): April 29, 2019

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: strabismus; automated; angle measurement
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus
• Other Study ID Numbers: RC18_0062

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No