Completed

PLH-VisionDevelopment of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 3 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2017
See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 20, 2017

Actual date on which the first participant was enrolled.

This study includes 3 phases: * Elaboration of a list of behavioral items by a group of multi-disciplinary expertise (physicians, nurses, caregivers, ophthalmologies, orthoptists) based on their clinical experiences. * Development of the scale based on the sample obtained by a prospective multicenter research trial. * Validation of the sample obtained by a prospective transversal multicenter study. This study will be performed in 5 centers in France. The enrollment of patients planned for 24 months targeting 310 patients. The duration of follow-up of the study for each patient will be varied according to the group of patients, il will be 1 day for group 1, 2 weeks for group 2, or 6 months for group 3.

Official TitleDevelopment of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
NCT03040609
Principal SponsorAssistance Publique - Hôpitaux de Paris
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

232 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 3 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
Causal brain injury occurred before the age of 3 years.
Severe or deep mental retardation as defined by DSM IV.
Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders.
Score of Gross Motor Function Classification System [Palisano 1997] is III, IV or V.
Show More Criteria
5 exclusion criteria prevent from participating
Acute intercurrent pathology precluding examinations.
Patient with hypersensitivity to tropicamide, atropine or benzalkonium chloride.
Angle closure glaucoma suspect patient.
Patient with severe hypertension.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hôpital San Salvadour

Hyères, FranceOpen Hôpital San Salvadour in Google Maps
CompletedOne Study Center