Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150391
• Other study ID #: CEI 046/23
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Hospital de Merida
• Contact: Maria Perez-Benito, Dra
• Phone: +34 655 77 12 31
• Email: mariaperezbe[@]salud-juntaex.es; mariapb6[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Amblyopia is a common neurodevelopmental abnormality that results in physiological alterations of the visual pathways and impaired vision in one eye or, less commonly, in both.Disruption of normal visual development early in life may result in perceptual, oculomotor and clinical abnormalities such as instability of fixation, anomalous retinal correspondence, and lack of stereoacuity.Amblyopia has a prevalence of around 2-4% in children and is associated with refractive error (anisometropia or isometropia) and strabismus. The Pediatric Eye Disease Investigator Group (PEDIG) has produced several studies that analyze the most effective therapies for amblyopic eye. The gold standard treatment prescribed for this condition combines spectacle correction of the refractive error with penalization and/or occlusion of the dominant eye 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. This randomized clinical trial is designed to evaluate the safety and clinical efficacy of a novel home-based system, based on a computer activity that uses dichoptic Gabor Patches and band-filtered noise masks. It combines the concepts of perceptual learning, dichoptic training, home based therapy and gamification. 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 as coadjuvant to pathching solve amblyopia in patients where 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 if this novel approach may lead to greater improvements in vision performance in amblyopic children as substitution of occlusion treatment in novel amblyopia or as coadjutant in persistent amblyopia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subjects with nystagmus, ocular pathology o cognitive delay will be excluded.

Related Conditions & MeSH terms

• Amblyopia

Intervention

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.
• 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

Locations

Country	Name	City	State
Spain	Servicio de Oftalmología del Hospital de Merida	Mérida	Extremadura

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Merida	VisionaryTool, S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA Best Corrected Visual Acuity	Best Corrected Visual Acuity is the measurement of the ability to distinguish shapes and the details of objects at a given distance wearing full refraction. Different optotipes are used to measure clinically this ability (e.g. Snellen E, ETDRS, etc.). Refraction must be calculated under cyclopegia following PEDIG criteria. Crowding bars can be added to the optotypes.; In this study, amblyopic eye BCVA will be measured using visual acuity chart ETDRS whitout crowding bars, in logarithmic scale.	Treatment will last 12 weeks, with BCVA measurements every 2 weeks. The stability control post treatment will last 12 months, with BCVA controls at 3, 6 and 12 months.
Secondary	Stereoacuity	In this stuty Randot Preschool Stereoacuity Test (Stereo Optical, Inc., Chicago, USA) will be used to asses stereoacuity in arc seconds. This is a random dot stereogram that measures global stereopsis (or cyclopean stereopsis) and does not contain monocular cues. Stereoacuity is measured at a constant distance of 40 cm.	Treatment will last 12 weeks, with stereoacuity measurements every 2 weeks. The stability control post treatment will last 12 months, with stereoacuity controls at 3, 6 and 12 months.

External Links

•   Visionary software webpage