Telerehabilitation for Visually Impaired

• Sponsor: Amore Filippo (Other)
• Overall Status: Completed
• CT.gov ID: NCT05772793
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 6.7
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Visual Impairment	Device: Telerehabilitation

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Usability and Adherence of Visually Impaired to Telerehabilitation: a Multicentre Study
• Actual Study Start Date: Jul 7, 2021
• Actual Primary Completion Date: Jan 27, 2022
• Actual Study Completion Date: Jan 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Group A	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.

Outcome Measures

Primary Outcome Measures

1. Utility of EyeFitness telerehabilitation [6 months]

   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).

Secondary Outcome Measures

1. Effect of treatment [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome		Italy	00168

Sponsors and Collaborators

• Amore Filippo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amore Filippo, Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05772793
• Other Study ID Numbers: 4244
• First Posted: Mar 16, 2023
• Last Update Posted: Mar 16, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vision Disorders; Vision, Low

Study Results

No Results Posted as of Mar 16, 2023