Retinitis PigmentosaPROSTNCT04448860
Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities
A study testing performance of behavioral locomotion tasks phase 1 and performance of behavioral locomotion tasks phase 2 in people with Retinitis Pigmentosa, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
Trial summary
the incidence of the disease of retinal degenerations with loss of photoreceptors (related to old age or genetic) on patients' daily lives, is poorly characterize without standardized means of measurement (usually performed with functional vision or reading tasks). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- performance of behavioral locomotion tasks phase 1 and performance of behavioral locomotion tasks phase 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2019to 4 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender male or female
- Non-syndromic pigmentary retinopathy: diagnosis confirmed by a specialist (RP patients)
- Pigmentary retinopathy with different damage's levels of visual field, acuity and sensitivity to contrasts (RP patients)
- Visual acuity of both corrected eyes (glasses, lenses) greater than or equal to 8/10 (or ≤ 0.1 logMAR) (Healthy volounteers)
- Normal semi-automated kinetic visual field (Healthy volounteers)
- Not participating in any other clinical trial that may interfere with this study
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- Sufficient knowledge of the French language to ensure understanding of the tasks to be performed and the instructions received
- Social insurance
- Consent signed after information by the investigator
Who cannot join
- Pregnant woman
- Inability to give personal consent
- Cataract surgery in the 3 months before inclusion
- Amblyopia
- Inability to comply with the instructions for the study tasks or to complete the study visits
- MMSE score without visual item ≤ 20/25 for RP patients
- MMSE score with visual item ≤ 25/30 for healthy volunteers
- Drug treatment which may cause motor, visual or cognitive disorders (neuroleptics, etc.) or which may interfere with study evaluations
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre hospitalier national d'ophtalmologique de 15-20
Paris, 75012
Saddek MOHAND-SAID, MD, 01 40 02 14 30/31, smohand-said@15-20.fr
About this study
the incidence of the disease of retinal degenerations with loss of photoreceptors (related to old age or genetic) on patients' daily lives, is poorly characterize without standardized means of measurement (usually performed with functional vision or reading tasks).
self-assessment by a quality of life questionnaire correlated with an assessment of emotional state and direct observation of patients during daily life tasks are the two ways used in a scientific framework to collect data on the difficulties encountered by patients in their daily life.
Read more
The aim of this project is to determine the behavioral effects of retinitis pigmentosa (RP) by the effects of performance reductions related to adapting to darkness and visual field restriction. Those assessments will be in real conditions but also in virtual reality (VR).
This tool can be used to measure a therapeutic benefit for new treatments (like gene therapy, retinal implants, intra vitreous injections …) for visual loss patients.
Read the detailed description
This prospective, longitudinal and non-randomized study will be conducted on 2 groups of people: retinitis pigmentosa's patients ( 1st and 2nd phases) and healthy volunteers patients (2nd phase).
The first phase's aim (named pilot phase) is to determine the optimal parameters to achieve the locomotion test. Fifteen RP's eligible patients will be requiring to 4 sessions of 3 hours to perform tests (Two sessions on real conditions and the two others on virtual reality).
The second phase's aim (named validation phase) is to validate tests to assess the impact of peripheral visual impairment on the sensory and motor performance of patients in their daily life. Firstly 15 RP's patients and 15 healthy volunteers will be included in this phase conducted according to a plan of Simon. 21 additional patients will be including on each group in view of the results on the first step in this 2nd phase.
For each patient, the duration of participation will be of 3 months for the first phase and 14 months for the second phase. The study duration is expected to be 50 months.
- Conditions
- Retinitis Pigmentosa
- Being tested
- performance of behavioral locomotion tasks phase 1, performance of behavioral locomotion tasks phase 2
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performance of behavioral locomotion tasks phase 1Behavioural
The performance of behavioral locomotion tasks is performed on 4 visits on pilot phase (2 in real condition and 2 in virtual reality in D1 and M1)
performance of behavioral locomotion tasks phase 2Behavioural
The performance of behavioral locomotion tasks is performed on 6 visits on validation phase (3 in real condition and 2 in virtual reality in D1, M1 and M12)
| Study group | Role | What they receive |
|---|---|---|
| Retinitis Pigmentosa patients | Experimental | Patients with Retinitis Pigmentosa (RP) at different stages of impairment of the visual field, acuity and sensitivity to contrasts 15 patients will be included in phase 1 versus 36 in phase 2 (15 in step 1 and 21 in step 2). Receives: Behavioral: performance of behavioral locomotion tasks phase 1; Behavioral: performance of behavioral locomotion tasks phase 2 |
| healthy volunteers patients | Other | 36 patients will be included just in phase 2 (15 in step 1 and 21 in step 2). Receives: Behavioral: performance of behavioral locomotion tasks phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot calibration phase in a real environment.
Defines the optimal parameters of complexity of standardized behavioral tasks thanks to a mobility test in variable light conditions carried out in a real environment.
Measured: Month 1
Pilot calibration phase in a virtual environment.
Defines the optimal parameters of complexity of standardized behavioral tasks thanks to a mobility test in variable light conditions carried out in a virtual environment.
Measured: Month 1
Validation phase on the motor performance
Validation of tests to assess the impact of peripheral visual impairment on the motor performance of patients in their daily life
Measured: Month 12
Validation phase on the sensory performance
Validation of tests to assess the impact of peripheral visual impairment on the sensory performance of patients in their daily life
Measured: Month 12
Secondary outcomes (4)
Validation of a locomotion test in virtual reality
It is to validate the construction of the test and to determine its performance in discriminating nature, its reproducibility and its sensitivity to change
Measured: Day 1 - Month 1- Month 12
Quality of Life Assessment
Analyze the correlation between the results of patients' quality of life and the results of behavioral tests
Measured: Day1-Month 1- Month 12
Measures of the evolution of the postural parameters
Evolution of postural's study parameters is performed by an experimental behavioral study, carried out during the same sessions as the main task of locomotion. The participants' postural stability will be correlated with the patient's visual parameters (acuity, visual field).
Measured: Day1 - Month 1 - Month 12
Analyze the adverse events during the tasks' assessment
Analyze the adverse events that will be collected during the performance of this study
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start4 Oct 2019
- Primary completion4 Oct 2023 (estimated)
- Study completion4 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies 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
- Sequential
- Model description
- optimal Simon two-stage design
- Masking
- None (open label)
- Enrolment
- 87 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
- Saddek MOHAND-SAID, MD, Principal investigator, Centre national d'ophtalmologique des 15-20
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448860
- Sponsor's protocol ID
- P19-02
- Other IDs
- 2019-A00483-54
- Acronym
- PROST
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities
- ClinicalTrials.gov ID
- NCT04448860
- Acronym / sponsor ID
- PROST / P19-02
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 4 Oct 2023 (estimated)
- Study completion
- 4 Oct 2023 (estimated)
- First posted
- 26 Jun 2020 (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 incidence of the disease of retinal degenerations with loss of photoreceptors (related to old age or genetic) on patients' daily lives, is poorly characterize without standardized means of measurement (usually performed with functional vision or reading tasks).
self-assessment by a quality of life questionnaire correlated with an assessment of emotional state and direct observation of patients during daily life tasks are the two ways used in a scientific framework to collect data on the difficulties encountered by patients in their daily life.
The aim of this project is to determine the behavioral effects of retinitis pigmentosa (RP) by the effects of performance reductions related to adapting to darkness and visual field restriction. Those assessments will be in real conditions but also in virtual reality (VR).
This tool can be used to measure a therapeutic benefit for new treatments (like gene therapy, retinal implants, intra vitreous injections …) for visual loss patients.
Detailed description
This prospective, longitudinal and non-randomized study will be conducted on 2 groups of people: retinitis pigmentosa's patients ( 1st and 2nd phases) and healthy volunteers patients (2nd phase).
The first phase's aim (named pilot phase) is to determine the optimal parameters to achieve the locomotion test. Fifteen RP's eligible patients will be requiring to 4 sessions of 3 hours to perform tests (Two sessions on real conditions and the two others on virtual reality).
The second phase's aim (named validation phase) is to validate tests to assess the impact of peripheral visual impairment on the sensory and motor performance of patients in their daily life. Firstly 15 RP's patients and 15 healthy volunteers will be included in this phase conducted according to a plan of Simon. 21 additional patients will be including on each group in view of the results on the first step in this 2nd phase.
For each patient, the duration of participation will be of 3 months for the first phase and 14 months for the second phase. The study duration is expected to be 50 months.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- optimal Simon two-stage design
| Arm | Type | Receives |
|---|---|---|
| Retinitis Pigmentosa patients | Experimental | Behavioral: performance of behavioral locomotion tasks phase 1, Behavioral: performance of behavioral locomotion tasks phase 2Patients with Retinitis Pigmentosa (RP) at different stages of impairment of the visual field, acuity and sensitivity to contrasts 15 patients will be included in phase 1 versus 36 in phase 2 (15 in step 1 and 21 in step 2). |
| healthy volunteers patients | Other | Behavioral: performance of behavioral locomotion tasks phase 236 patients will be included just in phase 2 (15 in step 1 and 21 in step 2). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Gender male or female
- Non-syndromic pigmentary retinopathy: diagnosis confirmed by a specialist (RP patients)
- Pigmentary retinopathy with different damage's levels of visual field, acuity and sensitivity to contrasts (RP patients)
- Visual acuity of both corrected eyes (glasses, lenses) greater than or equal to 8/10 (or ≤ 0.1 logMAR) (Healthy volounteers)
- Normal semi-automated kinetic visual field (Healthy volounteers)
Key exclusion criteria (8 listed)
- Pregnant woman
- Inability to give personal consent
- Cataract surgery in the 3 months before inclusion
- Amblyopia
- Inability to comply with the instructions for the study tasks or to complete the study visits
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 |
|---|---|---|
| performance of behavioral locomotion tasks phase 1The performance of behavioral locomotion tasks is performed on 4 visits on pilot phase (2 in real condition and 2 in virtual reality in D1 and M1) | Behavioural | Retinitis Pigmentosa patients |
| performance of behavioral locomotion tasks phase 2The performance of behavioral locomotion tasks is performed on 6 visits on validation phase (3 in real condition and 2 in virtual reality in D1, M1 and M12) | Behavioural | Retinitis Pigmentosa patients, healthy volunteers patients |
Primary outcome
Pilot calibration phase in a real environment.
Time frame: Month 1
Defines the optimal parameters of complexity of standardized behavioral tasks thanks to a mobility test in variable light conditions carried out in a real environment.
Pilot calibration phase in a virtual environment.
Time frame: Month 1
Defines the optimal parameters of complexity of standardized behavioral tasks thanks to a mobility test in variable light conditions carried out in a virtual environment.
Validation phase on the motor performance
Time frame: Month 12
Validation of tests to assess the impact of peripheral visual impairment on the motor performance of patients in their daily life
Validation phase on the sensory performance
Time frame: Month 12
Validation of tests to assess the impact of peripheral visual impairment on the sensory performance of patients in their daily life
4 secondary outcomes
Validation of a locomotion test in virtual reality
Time frame: Day 1 - Month 1- Month 12
Quality of Life Assessment
Time frame: Day1-Month 1- Month 12
Measures of the evolution of the postural parameters
Time frame: Day1 - Month 1 - Month 12
Analyze the adverse events during the tasks' assessment
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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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. This study is not recruiting at the moment.
Saddek MOHAND-SAID, MD principal investigator
Centre national d'ophtalmologique des 15-20
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing performance of behavioral locomotion tasks phase 1 and performance of behavioral locomotion tasks phase 2 in people with Retinitis Pigmentosa, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tania RILCY (+33140021126, trilcy@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pilot calibration phase in a real environment. (time frame: Month 1). The study lists 4 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 26 Jun 2020.