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Evaluation of the Visual Field on the Ground (ECVS)

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ClinicalTrials.gov Identifier: NCT03989622
Recruitment Status : Not yet recruiting
First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

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.


Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Syndrome Other: evaluation of the visual field on the ground Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Visual Field on the Ground: Impact on Locomotion Rehabilitation Adults With Retinitis Pigmentosa With Loss of Peripheral Vision
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: evaluation of the visual field on the ground
evaluation of the visual field on the ground followed by 10 reeducation sessions
Other: evaluation of the visual field on the ground
evaluation of the visual field on the ground

No Intervention: usual care
control session followed by 10 re-education sessions



Primary Outcome Measures :
  1. difference in the number of errors committed during a walk between T0 and T2 [ Time Frame: 2 months ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT03989622    
Other Study ID Numbers: I15007
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
Retinitis Pigmentosa
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn