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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02573-40 | Registry Identifier | IDRCB-ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Phase | Active Comparator | 12 patients with glaumatous optic neuropathy |
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| Validation Phase | Placebo Comparator | 66 patients with glaumatous optic neuropathy 12 subjects with no known visual impairment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilot Phase: standardized behavioral task | Behavioral | Pilot Phase:
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| Measure | Description | Time Frame |
|---|---|---|
| Discrimination capacity | Number of patients with capacity of discrimintaion compared to healthy volunteers | 6 months |
| Reproducibility of performance tests | Number of patients able to reproduce the same performance tests | 6 months |
| Analysis reationships between Performance Outcomes (PerfO), Patient-ReportedOutcome (PRO) and Clinical Outcomes. | Number of patients in each situation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Oculomotricity: |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nabil BROUK | Contact | +33140021126 | nbrouk@15-20.fr | |
| Hayet SERHANE | Contact | +33140021144 | hserhane@15-20.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christophe BAUDOUIN, Pr | Hôpital National de la Vision des15-20 | Principal Investigator |
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| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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Prospective, longitudinal, non-randomized, open-label study with glaucoma patients and control group (healthy volunteers)
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| Validation Phase: standardized behavioral task | Behavioral | Validation Phase:
|
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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. |
| 6 months |