TrialX
Image

Mobility Protocol Adapted for Advanced Visually Impaired Subjects

Mobility Protocol Adapted for Advanced Visually Impaired Subjects

Recruiting
18-75 years
All
Phase N/A

Overview

Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors, responsible for a progressive and severe loss of vision.

People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life, specifically for:

  • Visual research
  • Visuo-motor coordination in tasks requiring fine motor control
  • Visuo-motor coordination in mobility tasks

This study aims to assess the difficulties in the daily life of subjects with Retinitis Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified locomotion tasks in real situation and a posture task.

They are proposing a new test adapted and carried out in real situations, in binocular and monocular vision, making it possible to finely assess locomotion especially for "very low vision" patients.

This test will also ultimately make it possible to better evaluate the effectivements, that is to say to observe and quantify objectively by a score the performance progression obtained for locomotion tasks related to the visual recovery generated by the treatment.

Description

This is monocentric study and the total duration of the study is 48 months. The duration of participation for each research subject is 3 months and maximum 4 visits. This is research involving the human type of non-invasive interventional research, with minimal risks and constraints.

This exploratory study will be conducted on a group of patients with Retinitis Pigmentosa at a very advanced stage.

There will be an inclusion visit including a visual assessment and an ophthalmological consultation. Two experimental visits with tests carried out in a real environment including a locomotion and a posture tasks. An end-of-study visit within a maximum of 1 month following the second experimental visit.

Eligibility

Inclusion Criteria:

  • Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an ophtmalmologist
  • ETDRS visual acuity less than 2/10 (>+0.7 logMAR; <20/100 Snellen)
  • Doesn't participate in clinical research that may interfere with this study
  • Sufficient knowledge of the French language to ensure a perfect understanding of the tasks to be performed and the instructions received
  • Consent to the study signed after information by the investigator
  • Health insurance affiliation

Exclusion Criteria:

  • Pregnant women
  • Inability to give personal consent
  • Cataract surgery in the 3 months preceding inclusion
  • Amblyopia
  • Inability to comply with the instructions for carrying out the study tasks or to complete the study visits
  • MMSE score without visual item 20/25
  • Drug treatment which can lead to motor, visual or cognitive disorders (PSA, neuroleptics,etc.) or which may interfere with the study's evaluations

Study details
    Retinitis Pigmentosa
    Retinitis Pigmentosa

NCT04419285

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

16 February 2024

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.