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
About this trial
This is an interventional diagnostic trial for Retinitis Pigmentosa Syndrome focused on measuring Retinitis Pigmentosa
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
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
NCT ID
NCT03989622
First Posted
June 14, 2019
Last Updated
June 17, 2019
Sponsor
University Hospital, Limoges
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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Evaluation of the Visual Field on the Ground
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