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| Name | Class |
|---|---|
| VisionaryTool, S.L. | UNKNOWN |
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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group GA-E. Patients without previous occlusion o penalization treatment - Experimental | 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. |
|
| Group GA-C. Patients without previous occlusion o penalization treatment - Control | Active Comparator | 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. |
|
| Group GB-E. Patients with previous occlusion o penalization treatment - Experimental | 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. |
|
| Group GB-C. Patients with previous occlusion o penalization treatment - Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Perez-Benito, Dra | Contact | +34 655 77 12 31 | mariaperezbe@salud-juntaex.es; mariapb6@gmail.com | |
| Ana Sanchez-de-la-Morena, Dra | Contact | +34 924 38 10 00 | sau.merida@salud-juntaex.es |
| Name | Affiliation | Role |
|---|---|---|
| Teresa Calderon-Gonzalez, Lic | VisionaryTool, S.L. | Study Chair |
| Juan A. Portela-Camino, PhD | VisionaryTool, S.L. | Study Chair |
| Santiago Martin-Gonzalez, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de OftalmologÃa del Hospital de Merida | Recruiting | Mérida | Extremadura | 06800 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31030000 | Background | Verghese P, McKee SP, Levi DM. Attention deficits in Amblyopia. Curr Opin Psychol. 2019 Oct;29:199-204. doi: 10.1016/j.copsyc.2019.03.011. Epub 2019 Mar 22. | |
| 31704700 | Background | 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. |
| Label | URL |
|---|---|
| Visionary software webpage | View source |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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Participants will be divided in two groups: GA, 60 participants without previous occlusion treatment; GB, 60 participants with previous occlusion or penalization.
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.
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Ophthalmologists at the Pediatric Ophthalmologic Unit (Care Provider and Outcomes Assessor) will decide if volunteers meet inclusion criteria. They will assign the patient to GA or GB. They will be responsible for final and after treatment visual evaluations.
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.
| Active Comparator |
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. |
|
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| Patching | Device | 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 |
|
| VisionaryTool, S.L. |
| Study Chair |
| Maria Perez-Benito, Dra | Hospital de Merida | Principal Investigator |
| Esther Alvarez-Martin, Dra | Hospital de Merida | Study Chair |
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| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |