An interventional study of Pilot Phase: standardized behavioral task and Validation Phase: standardized behavioral task in Optic Neuropathy, sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Not applicable, Interventional, and Other
The impact of glaucomatous optic neuropathy on the daily life of patients is poorly characterized and does not benefit from standardized tests.
The development and validation of new tests could be used to assess the efficacy of innovative treatments for visually impaired patients and/or optimize management strategies.
This study will be conducted with 2 groups of subjects: glaucoma patients and healthy volunteers.
The objective of this project is to validate performance criteria (PerfO) using standardized tasks to assess the quality of life of patients but also to better judge the severity of glaucoma damage. The fidelity, reproducibility, validity and sensitivity of these new tests will be studied. This study will include two phases: a pilot phase to refine the parameters of the tests for the target population, and a validation phase for the tools.
This study will be performed in two phases: pilot phase and validation phase.
Pilot phase (12 months): 12 glaucoma patients (4 stage 1; 4 stage 2 and 4 stage 3), the objective of this phase is to define the optimal parameters of task content, as well as the conditions of luminosity and contrast.
Validation phase: 66 glaucoma patients classified into 3 groups of 22 patients according to the stage of severity (22 stage 1; 22 stage 2 and 22 stage 3) and 22 healthy volunteers matched for age and sex (matching rules ± 5 years).
The objective of this phase is to validate tests that will allow the evaluation of the impact of peripheral visual impairment on the sensory and motor performances of patients in their daily life.
128 studies on the registry are indexed under Optic Nerve Diseases; 27 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 84 interventional studies indexed under Optic Nerve Diseases.
Browse Optic Nerve Diseases studies →Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts is the lead sponsor of 28 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Glaucoma patients:
For the optional roadside fitness visit (V4), specific inclusion criteria will be required for this study: the roadside assessment will be performed with volunteers (GL and VS) who report being:
Healthy volunteer:
For the roadside fitness visit (V4), specific inclusion criteria will be required for this study: the roadside assessment will be performed with volunteers who declare themselves:
Exclusion Criteria:
12 patients with glaumatous optic neuropathy
Behavioral: Pilot Phase: standardized behavioral task
66 patients with glaumatous optic neuropathy 12 subjects with no known visual impairment
Behavioral: Validation Phase: standardized behavioral task
Pilot Phase: * Mobility under variable light conditions (scotopic, photopic, glare, dark adaptation), performed in a virtual environment. * Visual search for objects in real life scenes (office, kitchen, living room) performed in a virtual environment. * Ability to drive (UFOV and DVFAT psychophysical tests).
Validation Phase: * Mobility in variable light conditions (photopic and scotopic), performed in real and virtual environments. * Visual search for objects in real scenes (office, kitchen, bedroom, living room) performed in a virtual environment. * Driving ability (two psychophysical tests UFOV and DVFAT, one supervised road test).
Discrimination capacity
Number of patients with capacity of discrimintaion compared to healthy volunteers
Time frame: 6 months
Reproducibility of performance tests
Number of patients able to reproduce the same performance tests
Time frame: 6 months
Analysis reationships between Performance Outcomes (PerfO), Patient-ReportedOutcome (PRO) and Clinical Outcomes.
Number of patients in each situation
Time frame: 6 months
Postural control
Number of patients with modification of Romberg quotient to assess whether the central nervous system has re-weighted the weight of visual, vestibular and proprioceptive inputs with the onset of glaucomatous optic neuropathy.
Time frame: 6 months
Oculomotricity:
Number of patients with alteration of eye movement parameters during fixation tasks, ocular tracking (number of fixations, fixation error (gain), speed and number of catch-up saccades) and saccades) and ocular saccades.
Time frame: 6 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts