Visual dysfunction Eye Diseases Visual dysfunction
Conditions
Interventions
All the included participants will undergo a complete ophthalmologic assessment and an exam of visual functions with a novel digital test. The novel digital device (DIVE) consists of a high-resolution
Sponsors
Fundación Instituto de Investigación Sanitaria de Aragón (IIS Aragón)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 6 months and 14 years 2. Visual fixation stable enough to allow attentive fixation on the Lang cube 3. Assessments performed for all the following visual outcomes (although in some cases information may not be obtained): 3.1. External examination and red reflex 3.2. Visual acuity 3.3. Ocular motility 3.4. Refraction under cycloplegia 3.5. Funduscopy 4. Informed consent signed by parents or guardians of the child
Exclusion criteria
Exclusion criteria: 1. Previous ocular, muscular or orbital surgery. Since the main goal of the project is to develop a screening tool to identify children with abnormal visual development, children with any ocular or periocular surgery will be excluded from the study. However, children previously treated with optical correction, minor topic treatments or any therapy for amblyopia, will not be excluded, due to pragmatic reasons. Laser or intravitreal treatment for retinopathy of prematurity will not exclude a child. 2. Bad general health state, which does not allow an examination with DIVE. Lack of collaboration for performing the clinical protocol or the visual exam with DIVE is not an exclusion criterion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global visual development (normal/abnormal), defined by the ophthalmologist based on their clinical assessments at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| All the following outcomes will be assessed for the right eye, for the left eye and for both eyes at baseline: 1. Oculomotor control: fixation stability, saccadic reaction time, saccadic accuracy, smooth pursuit accuracy, assessed using the DIVE device 2. Grating visual acuity, assessed using the DIVE device 3. Contrast sensitivity, assessed using the DIVE device 4. Colour perception: deutan, protan and tritan axes, assessed using the DIVE device 5. Ophthalmic diagnosis provided by the ophthalmologist based on their clinical assessments | — |
Countries
Spain
Outcome results
None listed