Randomized Controlled Trial of a Dichoptic Gabor Videogame Program to Improve Visual Function in Children With Amblyopia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 12
Healthy Volunteers: f
View:

• The sample will be made up of children with amblyopia from 4 to 12 years old (amblyopia will be defined as the best corrected visual acuity less o equal to 0.8 in decimal units or \> 2 lines of difference between both eyes). Strabismus inclusion criteria will be \< 25 prismatic diopters, with a deviation ≥ 2 prismatic diopters.

Locations
Other Locations
Spain
Servicio de Oftalmología del Hospital de Merida
RECRUITING
Mérida
Contact Information
Primary
Maria Perez-Benito, Dra
mariaperezbe@salud-juntaex.es; mariapb6@gmail.com
+34 655 77 12 31
Backup
Ana Sanchez-de-la-Morena, Dra
sau.merida@salud-juntaex.es
+34 924 38 10 00
Time Frame
Start Date: 2023-10-05
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 120
Treatments
Experimental: Group GA-E. Patients without previous occlusion o penalization treatment - Experimental
GA-E volunteers (experimental) will be prescribed home therapy using computer-based exercises (Visionary) for 12 weeks, five days week, ½ half hour per day. Visionary target frequencies will be adjusted, considering BCVA, each three weeks. Contrast of Gabor patch frequencies will be adjusted to match patient contrast sensitivity thresholds.~In case BCVA does not improve at least 2 lines in two consecutive visits (6 weeks), patients will change to GA-C.
Active_comparator: Group GA-C. Patients without previous occlusion o penalization treatment - Control
GA-C patients (control) will be prescribed occlusion following Pediatric Eye Disease Investigation Group (PEDIG) criteria: 2 hours for mild and moderate amblyopia or 6 hours for severe amblyopia. Patients will receive a calendar to track patching accomplishment.~In case BCVA does not improve at least 2 lines in two consecutive visits (6 weeks), patients will change to GA-E.
Experimental: Group GB-E. Patients with previous occlusion o penalization treatment - Experimental
GB-E volunteers will receive occlusion following PEDIG criteria and will be prescribed home therapy using Visionary. Patients will receive a calendar to track patching accomplishment.~Visionary target frequencies will be adjusted, considering BCVA, each three weeks.
Active_comparator: Group GB-C. Patients with previous occlusion o penalization treatment - Control
GB-C volunteers will receive occlusion following PEDIG criteria and will be prescribed home therapy using Visionary. Patients will receive a calendar to track patching accomplishment.~Visionary target frequencies will always be low, no matter patient VA.~In case BCVA does not improve at least 2 lines in two consecutive visits (6 weeks), patients will be move to GB-E.
Related Therapeutic Areas
Sponsors
Collaborators: VisionaryTool, S.L.
Leads: Hospital de Merida

This content was sourced from clinicaltrials.gov