Pigmentary RetinopathyPROMANCT04419285
Mobility Protocol Adapted for Advanced Visually Impaired Subjects
A study testing Locomotion task, Posturology task SOT (Sensory Organization Test) and The quality of life questionnaire in people with Pigmentary Retinopathy, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
Trial summary
Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors, responsible for a progressive and severe loss of vision. People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life, specifically for: Visual research Visuo-motor coordination in tasks requiring… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pigmentary Retinopathy
- What is being tested?
- Locomotion task, Posturology task SOT (Sensory Organization Test) and The quality of life questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2020to 4 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an ophtmalmologist
- ETDRS visual acuity less than 2/10 (>+0.7 logMAR; <20/100 Snellen)
- Doesn't participate in clinical research that may interfere with this study
- Sufficient knowledge of the French language to ensure a perfect understanding of the tasks to be performed and the instructions received
- Consent to the study signed after information by the investigator
- Health insurance affiliation
Who cannot join
- Pregnant women
- Inability to give personal consent
- Cataract surgery in the 3 months preceding inclusion
- Amblyopia
- Inability to comply with the instructions for carrying out the study tasks or to complete the study visits
- MMSE score without visual item ≤ 20/25
- Drug treatment which can lead to motor, visual or cognitive disorders (PSA, neuroleptics,etc.) or which may interfere with the study's evaluations
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
Saddek SM MOHAND-SAID, MD, 01400021421, smolhand@15-20.fr
About this study
Official title: Design of a Mobility Protocol to Assess the Impact of Visual Pathologies in Daily Life Activities for Subjects With Advanced Visual Deficits
Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors, responsible for a progressive and severe loss of vision.
People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life, specifically for:
Read more
- Visual research
- Visuo-motor coordination in tasks requiring fine motor control
- Visuo-motor coordination in mobility tasks
This study aims to assess the difficulties in the daily life of subjects with Retinitis Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified locomotion tasks in real situation and a posture task.
They are proposing a new test adapted and carried out in real situations, in binocular and monocular vision, making it possible to finely assess locomotion especially for "very low vision" patients.
This test will also ultimately make it possible to better evaluate the effectivements, that is to say to observe and quantify objectively by a score the performance progression obtained for locomotion tasks related to the visual recovery generated by the treatment.
Read the detailed description
This is monocentric study and the total duration of the study is 48 months. The duration of participation for each research subject is 3 months and maximum 4 visits. This is research involving the human type of non-invasive interventional research, with minimal risks and constraints.
This exploratory study will be conducted on a group of patients with Retinitis Pigmentosa at a very advanced stage.
There will be an inclusion visit including a visual assessment and an ophthalmological consultation. Two experimental visits with tests carried out in a real environment including a locomotion and a posture tasks. An end-of-study visit within a maximum of 1 month following the second experimental visit.
- Conditions
- Pigmentary Retinopathy
- Being tested
- Locomotion task, Posturology task SOT (Sensory Organization Test), The quality of life questionnaire
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locomotion taskBehavioural
Also called Streetlab platform
The locomotion task takes place on a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns.
Posturology task SOT (Sensory Organization Test)Behavioural
Also called Streetlab platform, Opal MobilityLab
The task takes place on a Streetlab platform with uniform walls without decorations in order to remove any localization element.
The quality of life questionnaireBehavioural
Also called NEI-VFQ-25, ULV VFQ (Ultra Low Vision Visual Funnctioning Questionnaire)
Study the correlations between the subjects' quality of life scores and the results during behavioral tests. Identify the subjective parameters most sensitive to sensory-motor performance.
| Study group | Role | What they receive |
|---|---|---|
| Retinitis Pigmentosa patients | Experimental | 50 patients with very severe Retinitis Pigmentosa Receives: Behavioral: Locomotion task; Behavioral: Posturology task SOT (Sensory Organization Test); Behavioral: The quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discriminating
Study of the correlation between the severity of the impairment with regard to visual evaluations (visual acuity, visual field, ect) and the performance score for locomotion and posture tests.
Measured: Month 1
Reproducibility
Graphical and tabular representations will be prepared to represent the correlation between test results and visual function measures on the one hand and daily life activities on the other.
Measured: Month 1
Validity of construction
Graphical and tabular representations will be prepared to represent the correlation between test results and visual function measures on the one hand and daily life activities on the other.
Measured: Month 1
Secondary outcomes (1)
Measurement of postural parameters
The locomotion task which takes place in a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns. For the other tests, the number of turns and the distance to be covered are identical, but the shapes of the courses are systematically different.
The posturology task SOT (Sensory Organization Test) takes place in a StreetLab platform with uniform walls without decorations so as to remove any localization element.
The subject is instructed to stand with his hands on his hips as steadily as possible. This test includes 4 experimental conditions for disturbing sensory inputs. the duration of acquisition is 30 seconds, during which the subject must hold a standing position as tatic as possible, without speaking, els hands positioned on the hips while looking straight ahead. Four experimental conditions are tested: Eyes open on a hard floor, eyes closed on a hard floor, eyes open on a foam tray, eyes closed on a foam tray.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start2 Mar 2020
- Primary completion2 Jun 2024 (estimated)
- Study completion4 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmentary RetinopathyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The exploratory study will focus on 50 subjects with Retinitis Pigmentosa at very advanced stages
- Masking
- None (open label)
- Enrolment
- 50 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 SM MOHAND-SAID, MD, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419285
- Sponsor's protocol ID
- P19-04
- Other IDs
- 2019-A00937-50
- Acronym
- PROMA
- Status last verified
- Apr 2020
- First submitted
- 7 May 2020
- Last updated
- 5 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 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Mobility Protocol to Assess the Impact of Visual Pathologies in Daily Life Activities for Subjects With Advanced Visual Deficits
- ClinicalTrials.gov ID
- NCT04419285
- Acronym / sponsor ID
- PROMA / P19-04
- Conditions
- Pigmentary Retinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 2 Jun 2024 (estimated)
- Study completion
- 4 Jun 2024 (estimated)
- First posted
- 5 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.
Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors, responsible for a progressive and severe loss of vision.
People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life, specifically for:
- Visual research
- Visuo-motor coordination in tasks requiring fine motor control
- Visuo-motor coordination in mobility tasks
This study aims to assess the difficulties in the daily life of subjects with Retinitis Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified locomotion tasks in real situation and a posture task.
They are proposing a new test adapted and carried out in real situations, in binocular and monocular vision, making it possible to finely assess locomotion especially for "very low vision" patients.
This test will also ultimately make it possible to better evaluate the effectivements, that is to say to observe and quantify objectively by a score the performance progression obtained for locomotion tasks related to the visual recovery generated by the treatment.
Detailed description
This is monocentric study and the total duration of the study is 48 months. The duration of participation for each research subject is 3 months and maximum 4 visits. This is research involving the human type of non-invasive interventional research, with minimal risks and constraints.
This exploratory study will be conducted on a group of patients with Retinitis Pigmentosa at a very advanced stage.
There will be an inclusion visit including a visual assessment and an ophthalmological consultation. Two experimental visits with tests carried out in a real environment including a locomotion and a posture tasks. An end-of-study visit within a maximum of 1 month following the second experimental visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The exploratory study will focus on 50 subjects with Retinitis Pigmentosa at very advanced stages
| Arm | Type | Receives |
|---|---|---|
| Retinitis Pigmentosa patients | Experimental | Behavioral: Locomotion task, Behavioral: Posturology task SOT (Sensory Organization Test), Behavioral: The quality of life questionnaire50 patients with very severe Retinitis Pigmentosa |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an ophtmalmologist
- ETDRS visual acuity less than 2/10 (>+0.7 logMAR; <20/100 Snellen)
- Doesn't participate in clinical research that may interfere with this study
- Sufficient knowledge of the French language to ensure a perfect understanding of the tasks to be performed and the instructions received
- Consent to the study signed after information by the investigator
Key exclusion criteria (7 listed)
- Pregnant women
- Inability to give personal consent
- Cataract surgery in the 3 months preceding inclusion
- Amblyopia
- Inability to comply with the instructions for carrying out 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 |
|---|---|---|
| Locomotion taskAlso: Streetlab platformThe locomotion task takes place on a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns. | Behavioural | Retinitis Pigmentosa patients |
| Posturology task SOT (Sensory Organization Test)Also: Streetlab platform, Opal MobilityLabThe task takes place on a Streetlab platform with uniform walls without decorations in order to remove any localization element. | Behavioural | Retinitis Pigmentosa patients |
| The quality of life questionnaireAlso: NEI-VFQ-25, ULV VFQ (Ultra Low Vision Visual Funnctioning Questionnaire)Study the correlations between the subjects' quality of life scores and the results during behavioral tests. Identify the subjective parameters most sensitive to sensory-motor performance. | Behavioural | Retinitis Pigmentosa patients |
Primary outcome
Discriminating
Time frame: Month 1
Study of the correlation between the severity of the impairment with regard to visual evaluations (visual acuity, visual field, ect) and the performance score for locomotion and posture tests.
Reproducibility
Time frame: Month 1
Graphical and tabular representations will be prepared to represent the correlation between test results and visual function measures on the one hand and daily life activities on the other.
Validity of construction
Time frame: Month 1
Graphical and tabular representations will be prepared to represent the correlation between test results and visual function measures on the one hand and daily life activities on the other.
1 secondary outcome
Measurement of postural parameters
Time frame: Month 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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 SM MOHAND-SAID, MD principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locomotion task, Posturology task SOT (Sensory Organization Test) and The quality of life questionnaire in people with Pigmentary Retinopathy, 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 6 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: status not confirmed, as of the sponsor's last update on 5 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 TR 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?
Discriminating (time frame: Month 1). 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 5 Jun 2020.