Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program

Summary

Interest in developing alternative methods for the treatment of amblyopia (lazy eye) has long been a topic of interest among clinicians and researchers. Occlusion or penalization of fellow eye do not always provide the desired visual acuity improvement. Moreover, occlusion is associated with a high risk of recurrence and non-compliance. Here, it is presented a protocol of a randomized clinical trial to evaluate the safety and clinical efficacy of a novel home-based system, based on a computer game.

The goal of this prospective clinical trial is to compare in visual acuity improvements in patients with amblyopia, following conventional patching therapy or this novel computer-based therapy.

The main questions it aims to answer are:

* Does computer-based therapy equal or improve patching therapy? Can it be used as an alternative to patching?
* Does computer-based therapy used in combination with pathching solve amblyopia when patching fails alone (persistent amblyopia)?

Participants will be divided in two groups according to the previous occlusion o penalization of fellow eye. Both groups will be divided in two subgroups, experimental and control. Researchers will compare subgroups outcomes in order to asses this novel approach.

Conditions

• Amblyopia

Interventions

DEVICE

Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks

Visionary exercises are computer gammified activities that run on a computer with internet connection to facilitate home therapy. Patient must wear anaglyph glasses. Visual stimuli consists in dichoptic Gabor Patches presented to the amblyopic eye. Frequency is adjusted to actual patient visual acuity, and contrast to actual patient performance (contrast sensitivity). A band-filtered noise mask at the same frequency than the Gabor patch is presented to the fellow eye in certain ocassions.

DEVICE

Patching

PEDIG (Pediatric Eye Disease Investigator Group) recommended amblyopia treatment. Consist on covering a child's better-seeing eye with a patch for 2 hours per day for mild and moderate amblyopia or 6 hours per day for severe amblyopia

Sponsors & Collaborators

• VisionaryTool, S.L.

  collaborator UNKNOWN

• Hospital de Merida

  lead OTHER

Principal Investigators

• Teresa Calderon-Gonzalez, Lic · VisionaryTool, S.L.

• Juan A. Portela-Camino, PhD · VisionaryTool, S.L.

• Santiago Martin-Gonzalez, PhD · VisionaryTool, S.L.

• Maria Perez-Benito, Dra · Hospital de Merida

• Esther Alvarez-Martin, Dra · Hospital de Merida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-05

Primary Completion

2024-09-30

Completion

2024-09-30

Countries

• Spain

Study Locations