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CompletedNCT05772793Updated Mar 16, 2023

Telerehabilitation for Visually Impaired

An observational study in Visual Impairment, sponsored by Amore Filippo. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by Amore Filippo · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Visual Impairment
03

In context

Vision Disorders

308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.

This study's enrollment of 50 is below the median of 125 across 84 observational studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Amore Filippo is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Group A

    Device: Telerehabilitation

Interventions

  • DeviceTelerehabilitation

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Rome, 00168, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05772793
Lead sponsor
Amore Filippo
Responsible party
Amore Filippo (Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Sponsor-investigator
First posted
Mar 16, 2023
Start date
Jul 7, 2021
Primary completion
Jan 27, 2022
Completion
Jan 27, 2022
Last update
Mar 16, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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