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Completed

NCT Number: NCT03596138

Reliability and Reproducibility of Automated Angular Measurement in Strabismus

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nantes

Nantes, 44000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. Intra-class correlation coefficient

    Time frame: 12 months

    Intra-class correlation coefficient calculated on the 4 measures (2 of each technique) of each patient taken at time 1 by the same assessor.

Secondary outcomes

  1. Intra-class correlation coefficient using measurements

    Time frame: 12 months

    Intra-class correlation coefficient using measurements from each technique between 2 different evaluators at time 1

  2. Intraclass correlation coefficient using time 1 and time 2 measurements

    Time frame: 12 months

    Intraclass correlation coefficient using time 1 and time 2 measurements with the same investigator

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: FREGMA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2018
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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