Mobility Protocol Adapted for Advanced Visually Impaired Subjects

Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

Discriminating

Secondary Outcome

 Measurement of postural parameters

Condition

Pigmentary Retinopathy

Intervention

Locomotion task

Study Arms / Comparison Groups

 Retinitis Pigmentosa patients
Description:  50 patients with very severe Retinitis Pigmentosa

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

50

Start Date

March 2, 2020

Completion Date

June 4, 2024

Primary Completion Date

June 2, 2024

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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Saddek SM MOHAND-SAID, MD, +33140021126, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04419285

Organization ID

P19-04

Secondary IDs

2019-A00937-50

Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


Study Sponsor

Saddek SM MOHAND-SAID, MD, Principal Investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


Verification Date

April 2020