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Evaluation of the Visual Field on the Ground (ECVS)

Primary Purpose

Retinitis Pigmentosa Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
evaluation of the visual field on the ground
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Retinitis Pigmentosa Syndrome focused on measuring Retinitis Pigmentosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient at least 18 years old
  • patient with retinitis pigmentosa
  • a visual field less than or equal to 20 degrees regardless of the degree of visual acuity
  • lack of peripheral islets
  • to be able to move without a white detection cane
  • have signed an informed consent
  • be an affiliate or beneficiary of a French social security system.

Exclusion Criteria:

  • severe disorders of transparent media that may interfere with visual impairment related to retinitis pigmentosa
  • impossibility to follow the protocol
  • Limitation of locomotion activities related to other than visual impairments: neurological disorders (hemiplegia, neuropathy, ...)
  • musculoskeletal disorders (arthropathies ...)
  • Any participation in a protocol having an impact on the walking path by Virtual Reality
  • person under the protection of justice, or under guardianship or curators
  • pregnant or lactating woman

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    evaluation of the visual field on the ground

    usual care

    Arm Description

    evaluation of the visual field on the ground followed by 10 reeducation sessions

    control session followed by 10 re-education sessions

    Outcomes

    Primary Outcome Measures

    difference in the number of errors committed during a walk between T0 and T2
    difference in the number of errors committed (= number of hurdles, number of "doors" forgotten) during a walk between T0 (before ECVS) and T2 (after ECVS + 10 re-education sessions).

    Secondary Outcome Measures

    Full Information

    First Posted
    June 14, 2019
    Last Updated
    June 17, 2019
    Sponsor
    University Hospital, Limoges
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03989622
    Brief Title
    Evaluation of the Visual Field on the Ground
    Acronym
    ECVS
    Official Title
    Evaluation of the Visual Field on the Ground: Impact on Locomotion Rehabilitation Adults With Retinitis Pigmentosa With Loss of Peripheral Vision
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2019 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Limoges

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Retinopathy pigmentosa (which affects about 40,000 patients in France) leads to destruction of the peripheral retina. This condition, often familial, frequently affects young patients. Visual acuity is excellent for a long time, the disease affecting the central macular region only belatedly. On the other hand, the visual field is very quickly narrowed to a central or paracentral zone. For the patient, knowing the limits of his visual field and learning to adapt is necessary especially when traveling. The management of these patients is twofold: an orthoptist carries out an overall evaluation of the visual field using the Goldmann device (30 cm projection of the areas seen and not seen by the patient's eye), then performs rehabilitation over several weeks an instructor of locomotion (open specialization: occupational therapist, case of this project,...) carries out an evaluation in situation, followed by a personalized reeducation over several weeks. The first sessions consist in establishing a climate of confidence, presenting the objectives of the management of locomotion and begin to understand the movements inside and outside accompanied. The following of the rehabilitation is an apprenticeship of the optimal use of the residual field of vision and the proposed technical aids (white cane), in the whole of the displacements, inside and outside. The residual field of vision is evaluated by a device at the first appointment at the specialized center. This examination, necessary for the professional, is not informative for the patient. It is sometimes supplemented by the evaluation of the visual field of view (ECVS). The ECVS, done jointly by the orthoptist and the locomotion instructor, consists in evaluating the functional visual field on a horizontal plane at 1m (meter) and 5m, and vertical at 5m. The field of vision of the patient, immobile, is materialized by targets deposited at each limit of the zones seen that it indicates. The investigators believe that the passing of a visual field on the ground, thanks to the projection of the zones of vision, allows the patient to improve his knowledge on his visual possibilities (and gaps) and thus to make his reeducation more efficient.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinitis Pigmentosa Syndrome
    Keywords
    Retinitis Pigmentosa

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    evaluation of the visual field on the ground
    Arm Type
    Experimental
    Arm Description
    evaluation of the visual field on the ground followed by 10 reeducation sessions
    Arm Title
    usual care
    Arm Type
    No Intervention
    Arm Description
    control session followed by 10 re-education sessions
    Intervention Type
    Other
    Intervention Name(s)
    evaluation of the visual field on the ground
    Intervention Description
    evaluation of the visual field on the ground
    Primary Outcome Measure Information:
    Title
    difference in the number of errors committed during a walk between T0 and T2
    Description
    difference in the number of errors committed (= number of hurdles, number of "doors" forgotten) during a walk between T0 (before ECVS) and T2 (after ECVS + 10 re-education sessions).
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient at least 18 years old patient with retinitis pigmentosa a visual field less than or equal to 20 degrees regardless of the degree of visual acuity lack of peripheral islets to be able to move without a white detection cane have signed an informed consent be an affiliate or beneficiary of a French social security system. Exclusion Criteria: severe disorders of transparent media that may interfere with visual impairment related to retinitis pigmentosa impossibility to follow the protocol Limitation of locomotion activities related to other than visual impairments: neurological disorders (hemiplegia, neuropathy, ...) musculoskeletal disorders (arthropathies ...) Any participation in a protocol having an impact on the walking path by Virtual Reality person under the protection of justice, or under guardianship or curators pregnant or lactating woman

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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