Evaluation of the Visual Field on the Ground (ECVS)

Evaluation of the Visual Field on the Ground: Impact on Locomotion Rehabilitation Adults With Retinitis Pigmentosa With Loss of Peripheral Vision

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Retinitis Pigmentosa Syndrome
• Intervention / Treatment: Other: evaluation of the visual field on the ground

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (ACTUAL): June 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Retinitis Pigmentosa
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: I15007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No