Optic NeuropathySTRATAL-GLNCT05747781
STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient
A study testing Pilot Phase: standardized behavioral task and Validation Phase: standardized behavioral task in people with Optic Neuropathy, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Neuropathy
- What is being tested?
- Pilot Phase: standardized behavioral task and Validation Phase: standardized behavioral task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Glaucoma patients:
- Age: 18 - 80 years,
- Visual acuity of at least 6/10th binocular,
- Patient followed at Quinze-Vingts and presenting with chronic stable glaucoma defined by the glaucoma ophthalmologist,
- MMSE questionnaire score ≥ 25/30 or ≥ 16/25 (if the patient no longer drives),
- Ability to give consent and comply with the study protocol,
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- Person with Social Security coverage.
- Recruitment of glaucoma patients will be based on the criteria defined by the HPA classification (Appendix) on the basis of the Humphrey visual field, for categorization of patients into three stages of optic neuropathy progression (early stage "1", moderate "2" and advanced "3").
- 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:
- Always drivers in possession of a valid driver's license,
- Driven at least 500 km in the past year.
- Healthy volunteer:
- Age: 18 - 80 years.
- Age and sex matching between healthy volunteers and glaucoma patients (± 5 years).
- MMSE questionnaire score ≥ 25/30.
- Visual acuity of at least 10/10th in binocular.
- Ability to give consent and comply with the study protocol.
- Person with a Social Security plan.
- 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:
- Always drivers in possession of a valid driver's license,
- Driven at least 500 km in the past year.
Who cannot join
- Pregnant women.
- Inability to personally give consent.
- Participants will not have neurodegenerative diseases or any other disease that could interfere with the assessments planned during this study.
- Participants will not have any other ophthalmologic diseases other than glaucoma.
- Drug treatments that may cause motor, visual, or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with the study assessments.
- Condition that limits ability to move.
- Inability to read.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation of Standardized Tests Allowing the Evaluation of the Impacts of Glaucomatous Optic Neuropathy in Daily Life Activities
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.
Read the detailed description
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.
- Conditions
- Optic Neuropathy
- Being tested
- Pilot Phase: standardized behavioral task, Validation Phase: standardized behavioral task
- Medical subject headings
- Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot Phase: standardized behavioral taskBehavioural
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: standardized behavioral taskBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Pilot Phase | Active comparator | 12 patients with glaumatous optic neuropathy Receives: Behavioral: Pilot Phase: standardized behavioral task |
| Validation Phase | Placebo comparator | 66 patients with glaumatous optic neuropathy 12 subjects with no known visual impairment Receives: Behavioral: Validation Phase: standardized behavioral task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrimination capacity
Number of patients with capacity of discrimintaion compared to healthy volunteers
Measured: 6 months
Reproducibility of performance tests
Number of patients able to reproduce the same performance tests
Measured: 6 months
Analysis reationships between Performance Outcomes (PerfO), Patient-ReportedOutcome (PRO) and Clinical Outcomes.
Number of patients in each situation
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, longitudinal, non-randomized, open-label study with glaucoma patients and control group (healthy volunteers)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe BAUDOUIN, Pr, Principal investigator, Hôpital National de la Vision des15-20
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747781
- Sponsor's protocol ID
- P22-05
- Other IDs
- 2022-A02573-40
- Acronym
- STRATAL-GL
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Standardized Tests Allowing the Evaluation of the Impacts of Glaucomatous Optic Neuropathy in Daily Life Activities
- ClinicalTrials.gov ID
- NCT05747781
- Acronym / sponsor ID
- STRATAL-GL / P22-05
- Conditions
- Optic Neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, longitudinal, non-randomized, open-label study with glaucoma patients and control group (healthy volunteers)
| Arm | Type | Receives |
|---|---|---|
| Pilot Phase | Active comparator | Behavioral: Pilot Phase: standardized behavioral task12 patients with glaumatous optic neuropathy |
| Validation Phase | Placebo comparator | Behavioral: Validation Phase: standardized behavioral task66 patients with glaumatous optic neuropathy 12 subjects with no known visual impairment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age: 18 - 80 years,
- Visual acuity of at least 6/10th binocular,
- Patient followed at Quinze-Vingts and presenting with chronic stable glaucoma defined by the glaucoma ophthalmologist,
- MMSE questionnaire score ≥ 25/30 or ≥ 16/25 (if the patient no longer drives),
- Ability to give consent and comply with the study protocol,
Key exclusion criteria (7 listed)
- Pregnant women.
- Inability to personally give consent.
- Participants will not have neurodegenerative diseases or any other disease that could interfere with the assessments planned during this study.
- Participants will not have any other ophthalmologic diseases other than glaucoma.
- Drug treatments that may cause motor, visual, or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with the study assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilot Phase: standardized behavioral taskPilot 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). | Behavioural | Pilot Phase |
| Validation Phase: standardized behavioral taskValidation 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). | Behavioural | Validation Phase |
Primary outcome
Discrimination capacity
Time frame: 6 months
Number of patients with capacity of discrimintaion compared to healthy volunteers
Reproducibility of performance tests
Time frame: 6 months
Number of patients able to reproduce the same performance tests
Analysis reationships between Performance Outcomes (PerfO), Patient-ReportedOutcome (PRO) and Clinical Outcomes.
Time frame: 6 months
Number of patients in each situation
2 secondary outcomes
Postural control
Time frame: 6 months
Oculomotricity:
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christophe BAUDOUIN, Pr principal investigator
Hôpital National de la Vision des15-20
Questions about this trial
What is this clinical trial studying?
A study testing Pilot Phase: standardized behavioral task and Validation Phase: standardized behavioral task in people with Optic Neuropathy, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabil BROUK (+33140021126, nbrouk@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discrimination capacity (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.