What this trial measures

• Preverbal Visual Assessment (PreViAs)Aim 1: 6, 9, and 12 months of age (corrected age if born preterm)

  The PreViAs (Preverbal Visual Assessment) is a questionnaire designed to assess visual cognitive behavior in infants under 24 months of age, through caregiver report. It consists of 30 questions that evaluate visual attention, communication, motor coordination, and processing skills. The questionnaire aims to identify visual difficulties that may not be detected through standard vision tests, allowing for early intervention and support for children at risk for visual impairments.

• Visual AcuityAim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later

  This study will offer several age and cognitively appropriate assessments to test visual acuity. Each child will participate in a visual acuity test. Optotype (recognition acuity) test of binocular visual acuity (Lea Number, Lea Symbol, or other Snellen equivalent) chart will be measured at a distance and near. Teller Acuity cards (grading resolution acuity) will be used with infants and young children who are nonverbal or pre-verbal and do not require a verbal response.

• Contrast sensitivityAim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later.

  This study will offer several assessments to test visual function depending on age and cognitive ability. Contrast sensitivity threshold is a measure of visual function. Contrast sensitivity will be measured by the Heiding Heidi cards using 2 alternative forced choice, Lea symbols or numbers flip chart, Peli Robson near chart.

• Visual FieldsAim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later

  This study will offer several assessments to test the peripheral visual field depending on age and cognitive level. Assessing visual fields is a measure of visual function. Kinetic arc perimetry or confrontation visual field testing.

• Color VisionAim 2: At enrollment (baseline) and 12 months later

  This study will offer several assessments to test color vision depending on age and cognitive level. The American Optical Hardy-Rand-Ritler (AO HRR) color plates using symbol detection or Panel 16 Quantitative Color Vision Test - Double Set (D-16) using chip alignment or matching paradigm.

• Eye MotilityAim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later

  This study will offer several tests of eye motility depending on age and cognitive level. The following eye movements will be assessed by direct observation using developmentally appropriate targets: Fixation (absent, sporadic, unstable, stable); Smooth pursuit (absent, discontinuous, normal); Saccades (absent, hypometric, normal), and alignment to both distant and near targets. We will also measure eye gaze using a video-based eye tracking system.

• Objects in motionAim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later

  The ability to recognize objects that are in motion or the inability to recognize and/or attend to objects without motion. This will be assessed through clinical observation and parent report.

• AccomodationAim 1: If/when visual concerns are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months of age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later.

  Accommodative response will be measured through dynamic retinoscopy or the monocular estimation method.

• Stereo AcuityAim 2: At enrollment (baseline) and 12 months later

  Stereoacuity will be administered at near (40cm) in current spectacle correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity is defined as the smallest disparity in which the subject can correctly name or match at least 3 out of 4 target objects in the Randot Preschool stereoacuity tests.

• Hemispatial neglectAim 2: At enrollment (baseline) and 12 months later

  Hemispatial neglect is measured when indicated using line bisection, Teddy Bear, and/or bell test.

• Object recognitionAim 2: At enrollment (baseline) and 12 months later.

  Formal and informal measures of object recognition are used. Formal measures include Lea Symbols (color puzzle, black and white puzzle, 2D representation). Informal measures include recognition of 2D and 3D materials, both near and at a distance.

• Optic AtaxiaAim 2: At enrollment (baseline) and 12 months later

  The LEA Mailbox test will be used to evaluate optic ataxia. The movements of the wrist and fingers are observed as the subject attempts to pass a card through the slot of a large, round disc. The ability of the subject to move the card towards the slot and to orient in the direction of the slot will be recorded. Alternatively, for younger participants, toys such as a piggy bank will be used.

• Apraxia of the upper and lower limbAim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later

  Upper limb apraxia is measured through clinical observation of hand and arm movement toward an object of interest. This measurement will begin at 4 months of age. Lower limb apraxia will be measured through clinical observation of foot and leg movement toward an object of interest. This will be measured starting at 12 months of age.

• Spatial PerceptionAim 2: At enrollment (baseline) and 12 months later

  The ability to identify and match rectangles of different orientations and sizes using the Lea Rectangle game, shape sorter, or puzzles.

• SimultanagnosiaAim 2: At enrollment (baseline) and 12 months later

  The ability to attend to more than one object simultaneously will be assessed through clinical observation, AO HRR color plates, and birthday party test.

• Facial RecognitionAim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later

  The ability to recognize familiar and/or unfamiliar faces will be assessed through parent report, 9-gaze app and NEPSY.

• Facial ExpressionsAim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later

  The ability to interpret facial expresssions will be measured through parent report and Lea expressions test (two-alternative forced choice)

• Children's Visual Impairment Test (CVIT)Aim 2: At enrollment (baseline) and 12 months later

  This study will offer several assessments to test functional vision depending on age and ability level. The Children's Visual Impairment Test (CVIT) 3-6 is a measure of visual function. The CVIT is a standardized, non-verbal assessment designed to evaluate visual perceptual abilities in children aged 3 to 6 years who may have visual impairments or developmental delays. It is an assessment of how well a child can recognize and match visual patterns, independent of language or motor skills. It is completed on the computer. The domains assessed include form perception, spatial relationships, and object recognition.

• Beery-Buktenica Developmental test of Visual Motor Integration (Beery VMI)Aim 2: At enrollment (baseline) and 12 months later

  This study will offer several assessments to test functional vision depending on age and ability level. The Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI) is a measure of visual function. The Beery VMI is a standardized assessment tool designed to evaluate how well individuals can coordinate their visual perception and motor (finger and hand) control. There are three subtests. The main subtest is Visual Motor Integration and the optional subtests are Visual Perception and Motor Coordination. The Beery can be implemented with children 2-18 years. For this study, it will be implemented with children who have the ability to hold a pencil and complete pencil/paper tests.

• CVI RangeAim 2: At enrollment (baseline) and 12 months later

  This study will offer several assessments to test functional vision depending on age and ability level. The CVI Range is a measure of visual function developed by Dr. Christine Roman-Lantzy. The CVI Range is a functional assessment tool used to evaluate the visual abilities of individuals with Cortical/Cerebral Visual Impairment (CVI). The CVI Range helps determine how a person with CVI uses their vision in everyday settings. It is scored on a scale from 1-10 and can be used to assess children from 9 months to 18 years. In this study, it will be used to assess visual function in all participants.

• Austin AssessmentAim 2: At enrollment (baseline) and 12 months later

  The Austin Assessment will be used to measure eye movements and the ability to recognize and match cards with increasing complexity. The test measures search patterns, time to complete, accuracy, and time to initiate the task.

• A Developmental NEuroPSYchological Assessment (NEPSY) - Affect Recognition subtestAim 2: At enrollment (baseline) and 12 months later

  This study will offer several assessments to test functional vision depending on age and ability level. The NEPSY Affect Recognition subtest measures an aspect of visual function. It designed to assess a child's ability to recognize and interpret facial expressions of emotion. It's part of the Social Perception domain in the NEPSY-II battery. It can be administered to children between 4 to 16 years. It assesses matching faces showing the same emotion, identifying emotions from facial expressions and understanding subtle differences in affect.

• Bayley Scale of Infant Development (BSID-IV)Aim 2: Enrollment (Baseline) and 12 Months later

  The BSID-IV assesses the three neurodevelopmental domains of interest including cognition, language (receptive and expressive) and motor (fine and gross). The BSID will be used to test children 28 months and younger (corrected age if born preterm).

• The Peabody Developmental Motor Scales (PDMS)Aim 2: Enrollment (Baseline) and 12 Months later

  The Peabody Developmental Motor Scales (PDMS-2) is a standardized assessment tool used to evaluate gross and fine motor skills in children from birth through 5 years of age.

• Gross Motor Function Measure-66 (GMFM-66)Aim 2: Enrollment (Baseline) and 12 Months later

  The Gross Motor Function Measure-66 (GMFM-66) is a standardized observational assessment used to evaluate gross motor function in children with cerebral palsy and other motor impairments. It measures changes in gross motor abilities over time or in response to intervention. It can be used for children aged 5 months to 16 years,

• The Movement Assessment Battery for Children (MABC)Aim 2: At enrollment (baseline) and 12 months later

  The Movement Assessment Battery for Children (MABC) is a standardized tool used to assess motor coordination and movement difficulties in children and adolescents aged 3 to 16 years. It is used to identify motor impairments and supports diagnosis of conditions like Developmental Coordination Disorder (DCD).

• The Preschool Language Scales- 5th Edition (PLS-5)Aim 2: Enrollment (Baseline) and 12 Months later

  This study will offer several assessments to test speech and language, depending on age and ability level. The Preschool Language Scales, Fifth Edition (PLS-5) is a standardized assessment tool used to evaluate language development in children from birth through 7 years, 11 months. It assesses both receptive (understanding) and expressive (speaking) language skills.

• Rosetti Infant Toddler Language ScaleAim 2: At enrollment (baseline) and 12 months later

  This study will offer several assessments to test speech and language, depending on age and ability level. The Rossetti Infant-Toddler Language Scale is a criterion-referenced assessment tool used to evaluate communication and language development in children from birth to 3 years of age. It identifies delays in preverbal and verbal communication skills.

• Goldman Fristoe Test of Articulation (GFTA)Aim 2: At enrollment (baseline) and 12 months later

  This study will offer several assessments to test speech and language, depending on age and ability level. For children who present with an articulation deficit, the Goldman Fristoe Test of Articulation will be administered. The GFTA is a standardized assessment used to evaluate articulation skills in individuals aged 2 to 21 years.

• The Weschler Preschool & Primary Scale of Intelligence - Fourth Edition (WPPSI-IV)Aim 2: At enrollment (baseline) and 12 months later

  This study will offer several assessments to test cognition, depending on age and ability level. The Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV) is a standardized cognitive assessment designed for children aged 2 years 6 months to 7 years 7 months. It measures intellectual functioning and helps identify cognitive strengths and weaknesses.

• The Leiter International Performance Scale 3 (Leiter 3)Aim 2: At enrollment (baseline) and 12 months later

  This study will offer several assessments to test cognition, depending on age and ability level. The Leiter International Performance Scale - Third Edition (Leiter-3) is a nonverbal intelligence and cognitive abilities test designed for children aged 3 to 18 years. It assesses nonverbal IQ, attention, memory, and processing speed.