Telerehabilitation for Visually Impaired

Visual Impairment Clinical Trial

Official title:

Usability and Adherence of Visually Impaired to Telerehabilitation: a Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05772793
• Other study ID #: 4244
• Status: Completed
• Start date: July 7, 2021
• Est. completion date: January 27, 2022

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

the purpose of the study is to evaluate the software usability and patient's adherence from five vision rehabilitation centres. In addition, the effect and benefits of a customizable telerehabilitation program were tested.

Description:

The software is used in our practice for every day vision rehabilitation training. So it is part of our routine medical care, and a we are going to study studies the effect of the intervention in several different centers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All patients were eligible if they were over 18 years old and had a best corrected visual acuity (BCVA) between 1.3 logMAR and 0.4 LogMAR and/or a visual field of less than 60%, according to the WHO classification.

Exclusion Criteria:

• Subjects were excluded if they had a cognitive/psychiatric impairment or a motor disability that prevents the use of a computer pointing device (mouse).

Related Conditions & MeSH terms

• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Device:
• Telerehabilitation
The home visual telerehabilitation path using the EyeFitness software consisted of performing one visual training session per day, 5 days a week (from Monday to Friday) for a total of 6 weeks.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Amore Filippo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utility of EyeFitness telerehabilitation	The aim of this study is to evaluate the utility of the EyeFitness telerehabilitation software and the adherence of patients to the treatment.; In order to evaluate the utility of the software the primary outcome measures were PSSUQ Version 3 scores defined as Overall, System Usefulness (Sysuse), Information Quality (Infoqual), Interface Quality (Iterqual).	6 months
Secondary	Effect of treatment	The secondary outcome measures selected for the effectiveness analysis were distance Best Corrected Visual Acuity, MNRead reading acuity, reading speed (words per minute), contrast sensitivity (at Pelli - Robson charts) and fixation stability according to Microperimeter exame classification.	6 months