Clinical trial NCT04419285: Mobility Protocol Adapted for Advanced Visually Impaired Subjects
Official title: Design of a Mobility Protocol to Assess the Impact of Visual Pathologies in Daily Life Activities for Subjects With Advanced Visual Deficits
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pigmentary Retinopathy
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The exploratory study will focus on 50 subjects with Retinitis Pigmentosa at very advanced stages
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Discriminating
timeFrame: Month 1
measure: Reproducibility
timeFrame: Month 1
measure: Validity of construction
timeFrame: Month 1
Secondary outcomes:
measure: Measurement of postural parameters
timeFrame: Month 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Study officials:
affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
name: Saddek SM MOHAND-SAID, MD
role: PRINCIPAL_INVESTIGATOR
References: