Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program
NCT ID: NCT06150391
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-10-05
2024-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
In GA, participants will be assigned to an Experimental subgroup (GA-E) or to a Control subgroup (GA-C). GA-E volunteers will be prescribed computer-based exercises (Visionary). GA-C patients will be prescribed occlusion.
In GB, all participants will receive occlusion. There will be two subgroups, Experimental (GB-E) and Control (GB-C), and both will be prescribed exercises using Visionary. In GB-E the computer will adjust Gabor patches frequency to visual acuity, as normal; but in GB-C Gabor frequencies will always be low.
Importantly, those patients with deviations (10 to 25 prismatic diopters) will be assigned to experimental or treatment subgroups following an independent randomization.
TREATMENT
TRIPLE
The Quality Service of the Merida Hospital (Investigator) will randomize GA and GB volunteers into treatment or control subgroups. This service will be responsible for the custody of documentation and the statistical final analysis.
Visionary team (Investigator) will communicate the patient about the treatment (occlusion or Visionary software, or both).
Optometrists at the Pediatric Ophthalmologic Unit (Outcomes Assessor) will oversee BCVA and stereoacuity measurements during treatment.
Study Groups
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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.
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.
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.
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
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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Exclusion Criteria
4 Years
12 Years
ALL
No
Sponsors
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VisionaryTool, S.L.
UNKNOWN
Hospital de Merida
OTHER
Responsible Party
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Maria Perez-Benito
Dr.
Principal Investigators
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Teresa Calderon-Gonzalez, Lic
Role: STUDY_CHAIR
VisionaryTool, S.L.
Juan A. Portela-Camino, PhD
Role: STUDY_CHAIR
VisionaryTool, S.L.
Santiago Martin-Gonzalez, PhD
Role: STUDY_CHAIR
VisionaryTool, S.L.
Maria Perez-Benito, Dra
Role: PRINCIPAL_INVESTIGATOR
Hospital de Merida
Esther Alvarez-Martin, Dra
Role: STUDY_CHAIR
Hospital de Merida
Locations
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Servicio de Oftalmología del Hospital de Merida
Mérida, Extremadura, Spain
Countries
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Central Contacts
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Maria Perez-Benito, Dra
Role: CONTACT
Phone: +34 655 77 12 31
Email: [email protected]; [email protected]
Facility Contacts
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Maria Perez-Benito, Dra
Role: primary
Ana Sanchez-de-la-Morena, Dra
Role: backup
References
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Fu Z, Hong H, Su Z, Lou B, Pan CW, Liu H. Global prevalence of amblyopia and disease burden projections through 2040: a systematic review and meta-analysis. Br J Ophthalmol. 2020 Aug;104(8):1164-1170. doi: 10.1136/bjophthalmol-2019-314759. Epub 2019 Nov 8.
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Related Links
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Visionary software webpage
Other Identifiers
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CEI 046/23
Identifier Type: -
Identifier Source: org_study_id