NCT05014503: iVision2_WP3

A Computerized, Adaptive Therapeutic Gaming Approach Training Visual Perceptual Skills in Children With CVI

Completed NA Last updated 18 March 2025

What this trial tests

NA trial testing Adaptive Therapeutic gaming in Cerebral Visual Impairment in 73 participants. Completed in 31 December 2024.

Timeline

2 January 2022

Primary endpoint
30 May 2024

31 December 2024

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	73
Start date	2 January 2022
Primary completion	30 May 2024
Estimated completion	31 December 2024
Sites	1 location across Belgium

Drugs / interventions tested

• Adaptive Therapeutic gaming
• Non-adaptive Therapeutic gaming

Conditions studied

• Cerebral Visual Impairment — all drugs for Cerebral Visual Impairment →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 3 to 12, any sex, with Cerebral Visual Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial aims to compare the effectiveness of our adaptive, therapeutic game to the effectiveness of the same game, without the adaptive component. In the adaptive game, the game entry level is adapted to the visual perceptual capacities of the child, as defined by the visual perceptual profile. In addition, the difficulty level of the adaptive game will adapt itself to the gaming results and behaviour of the child. The non-adaptive version of the game consists of the same set of mini-games, but the entry-level is the same for all children (basic or 0 entry-level) and gradually increased, independent of the gaming results, success and behaviour of the child. The researchers will use a double-blind, randomized controlled trial design, including children with a developmental age between 3 and 12 years old, a diagnosis of CVI, acuity \>0.2, with sufficient manual coordination to control a mouse, keypad or touch screen. All children will use the gamified therapy program for three months, with a minimum of three times per week, 15- 20 minutes. A blinded evaluator will evaluate the effectiveness on the main components of the visual perceptual profile of the child (primary outcome), on eye tracking parameters, functional vision and quality of life, at the end and at three months follow-up. Enjoyment and user experience will be monitored closely during the intervention period. As usual and regular therapy of the children will not be influenced during the intervention period, we will ask the parents and/or caretaker to register all other relevant gaming and therapy activities performed during that period. It is hypothesized that children will benefit more from an individualized, adaptive training approach compared to the generic, non-adaptive version of the program.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Human retinal secretome: A cross-link between mesenchymal and retinal cells.
   Donato L, Scimone C, Alibrandi S, Scalinci SZ, et al · · 2023 · cited 6× · PMID 37545752 · DOI 10.4252/wjsc.v15.i7.665