Evaluation of the Visual Field on the Ground

NCT03989622 | Unknown

• 1 other identifier: I15007
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Retinitis Pigmentosa Syndrome

Keywords

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

• 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).

  2 months

Study Arms (2)

evaluation of the visual field on the ground

EXPERIMENTAL

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

Other: evaluation of the visual field on the ground

usual care

NO INTERVENTION

control session followed by 10 re-education sessions

Interventions

evaluation of the visual field on the ground OTHER

evaluation of the visual field on the ground

evaluation of the visual field on the ground

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

MeSH Terms

Conditions

RHYNS syndrome; Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share