Cerebral Visual ImpairmentCVI-NDNCT07212010

Neurodevelopmental Outcomes in Cerebral Visual Impairment

An observational study of Cerebral Visual Impairment, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 6 to 72 monthsHealthy volunteers can take part
Conditions the study is for: Cerebral Visual Impairment
How many people: 600 participants
Where: 1 siteUnited States
Study dates: 31 Jul 2025to Aug 2031
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 72 months
All sexes
Healthy volunteers accepted
Child

Study population: Aim 1: (at risk group) Children with medical and neuroimaging conditions that put children at high risk for cerebral visual impairment (control group) age matched peers without high-risk medical and neuroimaging conditions. Aim 2: Children with a diagnosis of cerebral visual impairment confirmed by a CVI multidisciplinary team visit.

Who may be able to join

Aim 1 (CVI Risk Group): Infants 8 months of age and who meet any of the following:
The presence of any of the following comorbid diagnoses (CVI risk criteria): brain injury, hypoxia/ischemia, congenital structural abnormalities of the brain, genetic syndromes, epilepsy, infantile spasms/seizures, central nervous system infection, intrauterine drug/alcohol exposure, brain volume loss, or periventricular leukomalacia.
Presence of any of the following abnormal neuro-imaging findings (CVI risk criteria): Vascular insults, underlying genetic/structural/migrational abnormality, brain atrophy, prematurity sequelae, hydrocephalus, presumed metabolic findings, presumed infection findings.
Aim 1: (control group): Infants less than 8 months of age negative for CVI risk criteria (see above).
Exclusion Criteria: Aim 1: (both groups): Known visually impairing conditions of the eyes and optic nerves (e.g., inherited retinal diseases, bilateral moderate-to-severe optic nerve hypoplasia), cataracts, retinopathy of prematurity with significant visual sequelae (e.g. macular ectopia or retinal detachment) will be excluded from the study to ensure CVI is the primary cause of a positive PreViAs screen.
Aim 2: Inclusion criteria:

Show all 13Show fewer

Children 12-< 60 months of age
Confirmed diagnosis of CVI
Children must meet at least 1 of these 2 criteria to confirm the diagnosis of CVI during a CVI clinic visit: I: (1) the presence of visual function impairment (e.g., visual acuity) not attributed to anterior visual pathway abnormalities (except mild optic atrophy) or 2) evidence of visual perception/functional vision deficit.
Aim 2: Exclusion Criteria:
Children with autism spectrum disorder
Children with ocular conditions including inherited retinal diseases, congenital cataracts, anterior segment dysgenesis, optic nerve hypoplasia, and retinopathy of prematurity with profound visual impairment due to anatomical abnormalities
A chart review will take place to review for exclusion criteria. Children who are identified with one of these potential exclusion criteria will be formally evaluated/screened through a neuro-ophthalmology exam to confirm the presence or absence of the exclusionary diagnoses in the chart. This will occur prior to consenting and/or scheduling any other testing.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Integrative Neurodevelopmental Approach to Cerebral Vision Impairment (CVI): Screening and Subtyping in Early Childhood

Cerebral visual impairment (CVI) is one of the leading causes of pediatric visual impairment and negatively impacts the development of motor, language, and cognitive skills. This study proposes to (1) establish a novel and easy to use CVI screening algorithm for infants and (2) develop CVI subtypes based on vision, motor, language, and cognition. The overarching goal is to identify CVI early and enhance our comprehension of CVI's impact on a child's development. The results will fundamentally change the approach to designing treatments for children with CVI.

Read the detailed description

Cerebral visual impairment (CVI) is the leading cause of visual impairment in children. Although the onset is typically early in life, diagnosis is often delayed until preschool age or later. Early identification is critical for optimal development. Vision is essential in incidental and intentional learning used to build foundational motor, language, and cognitive skills. The proposed research aims to (1) develop a screening algorithm for early detection of CVI and (2) establish neurodevelopmental profiles that will inform intervention for children diagnosed with CVI. The overarching hypothesis is that early detection of CVI and understanding the relationship between visual impairment and neurodevelopment are imperative for creating interventions to optimize a child's abilities. In the first aim, a novel screening algorithm for CVI detection in infants will be tested at three time points between 4-12 months corrected age. In the second aim, an interdisciplinary standardized assessment protocol will be utilized, including visual and developmental evaluations at two time points to create neurodevelopmental subtypes in young children with CVI. This proposal will be implemented by an interdisciplinary research team with a well-established track record of clinical practice and research in CVI. This innovative proposal will lead to a paradigm shift in the current approach to CVI management in young children. The findings from this study will lead to the development of a screening protocol for early detection of CVI that can be easily incorporated into medical practice by providers who routinely interact with young infants and, in time, become standard practice. Additionally, the established neurodevelopmental profiles will serve as the cornerstone for creating comprehensive clinical protocols guiding the care and treatment of children diagnosed with CVI.

Conditions: Cerebral Visual Impairment
Keywords: Cerebral visual impairment, screening, Neurodevelopment, vision, cortical visual impairment
Medical subject headings: Blindness, Cortical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07212010
Study group	Role	What they receive
Screening		This group will be screened for CVI in the first year of life. Children with positive screens for CVI will undergo a comprehensive CVI evaluation.
Neurodevelopment		Children in this group will participate in a multi-disciplinary CVI clinic as well as neurodevelopmental testing and a neuro-ophthalmic eye exam at baseline and 12 months later.

What is being measured

The primary outcome is the main question the study is designed to answer.

Preverbal Visual Assessment (PreViAs)
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.
Measured: Aim 1: 6, 9, and 12 months of age (corrected age if born preterm)
Visual Acuity
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.
Measured: Aim 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
Contrast sensitivity
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.
Measured: Aim 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.
Visual Fields
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.
Measured: Aim 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
Color Vision
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
Eye Motility
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.
Measured: Aim 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
Objects in motion
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.
Measured: Aim 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
Accomodation
Accommodative response will be measured through dynamic retinoscopy or the monocular estimation method.
Measured: Aim 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.
Stereo Acuity
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
Hemispatial neglect
Hemispatial neglect is measured when indicated using line bisection, Teddy Bear, and/or bell test.
Measured: Aim 2: At enrollment (baseline) and 12 months later
Object recognition
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later.
Optic Ataxia
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
Apraxia of the upper and lower limb
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.
Measured: Aim 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
Spatial Perception
The ability to identify and match rectangles of different orientations and sizes using the Lea Rectangle game, shape sorter, or puzzles.
Measured: Aim 2: At enrollment (baseline) and 12 months later
Simultanagnosia
The ability to attend to more than one object simultaneously will be assessed through clinical observation, AO HRR color plates, and birthday party test.
Measured: Aim 2: At enrollment (baseline) and 12 months later
Facial Recognition
The ability to recognize familiar and/or unfamiliar faces will be assessed through parent report, 9-gaze app and NEPSY.
Measured: Aim 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
Facial Expressions
The ability to interpret facial expresssions will be measured through parent report and Lea expressions test (two-alternative forced choice)
Measured: Aim 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
Children's Visual Impairment Test (CVIT)
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
Beery-Buktenica Developmental test of Visual Motor Integration (Beery VMI)
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
CVI Range
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
Austin Assessment
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
A Developmental NEuroPSYchological Assessment (NEPSY) - Affect Recognition subtest
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
Bayley Scale of Infant Development (BSID-IV)
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).
Measured: Aim 2: Enrollment (Baseline) and 12 Months later
The Peabody Developmental Motor Scales (PDMS)
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.
Measured: Aim 2: Enrollment (Baseline) and 12 Months later
Gross Motor Function Measure-66 (GMFM-66)
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,
Measured: Aim 2: Enrollment (Baseline) and 12 Months later
The Movement Assessment Battery for Children (MABC)
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).
Measured: Aim 2: At enrollment (baseline) and 12 months later
The Preschool Language Scales- 5th Edition (PLS-5)
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.
Measured: Aim 2: Enrollment (Baseline) and 12 Months later
Rosetti Infant Toddler Language Scale
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
Goldman Fristoe Test of Articulation (GFTA)
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
The Weschler Preschool & Primary Scale of Intelligence - Fourth Edition (WPPSI-IV)
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later
The Leiter International Performance Scale 3 (Leiter 3)
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.
Measured: Aim 2: At enrollment (baseline) and 12 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 2025Aug 2031

First posted8 Oct 2025
Study start31 Jul 2025
Primary completionAug 2030 (estimated)
Study completionAug 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cerebral Visual ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07212010
Sponsor's protocol ID: 2024-0772
Other IDs: R01EY036154-01A1
Acronym: CVI-ND
Status last verified: Oct 2025
First submitted: 22 Sep 2025
Last updated: 9 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruiting
SENSE-Brain Health Pro for Older Adults With Sensory Loss
Vision and Hearing Loss, Vision Impairment

All Cerebral Visual Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrative Neurodevelopmental Approach to Cerebral Vision Impairment (CVI): Screening and Subtyping in Early Childhood
ClinicalTrials.gov ID: NCT07212010
Acronym / sponsor ID: CVI-ND / 2024-0772
Conditions: Cerebral Visual Impairment
Keywords: Cerebral visual impairment, screening, Neurodevelopment, vision, cortical visual impairment
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 600 participants (estimated)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Collaborators: National Eye Institute (NEI)
Study start: 31 Jul 2025 (actual)
Primary completion: Aug 2030 (estimated)
Study completion: Aug 2031 (estimated)
First posted: 8 Oct 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Screening	–	–This group will be screened for CVI in the first year of life. Children with positive screens for CVI will undergo a comprehensive CVI evaluation.
Neurodevelopment	–	–Children in this group will participate in a multi-disciplinary CVI clinic as well as neurodevelopmental testing and a neuro-ophthalmic eye exam at baseline and 12 months later.

Who may qualify

Ages: 6 to 72 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Aim 1: (at risk group) Children with medical and neuroimaging conditions that put children at high risk for cerebral visual impairment (control group) age matched peers without high-risk medical and neuroimaging conditions. Aim 2: Children with a diagnosis of cerebral visual impairment confirmed by a CVI multidisciplinary team visit.

Key inclusion criteria (13 listed)

Aim 1 (CVI Risk Group): Infants 8 months of age and who meet any of the following:
Aim 1: (control group): Infants less than 8 months of age negative for CVI risk criteria (see above).
Exclusion Criteria: Aim 1: (both groups): Known visually impairing conditions of the eyes and optic nerves (e.g., inherited retinal diseases, bilateral moderate-to-severe optic nerve hypoplasia), cataracts, retinopathy of prematurity with significant visual sequelae (e.g. macular ectopia or retinal detachment) will be excluded from the study to ensure CVI is the primary cause of a positive PreViAs screen.
Children 12-< 60 months of age
Confirmed diagnosis of CVI

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Preverbal Visual Assessment (PreViAs)
Time frame: 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 Acuity
Time frame: Aim 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 sensitivity
Time frame: Aim 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 Fields
Time frame: Aim 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 Vision
Time frame: Aim 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 Motility
Time frame: Aim 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 motion
Time frame: Aim 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.
Accomodation
Time frame: Aim 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 Acuity
Time frame: Aim 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 neglect
Time frame: Aim 2: At enrollment (baseline) and 12 months later
Hemispatial neglect is measured when indicated using line bisection, Teddy Bear, and/or bell test.
Object recognition
Time frame: Aim 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 Ataxia
Time frame: Aim 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 limb
Time frame: Aim 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 Perception
Time frame: Aim 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.
Simultanagnosia
Time frame: Aim 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 Recognition
Time frame: Aim 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 Expressions
Time frame: Aim 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)
Time frame: 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)
Time frame: 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 Range
Time frame: 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 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 Assessment
Time frame: Aim 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 subtest
Time frame: 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 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Scale
Time frame: 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. 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Karen L Harpster, PhD, OTR/L principal investigator

Cincinnati Childrens Hospital Medical Center

Veeral Shah, MD principal investigator

Children's Hospital Medical Center, Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Visual Impairment, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preverbal Visual Assessment (PreViAs) (time frame: Aim 1: 6, 9, and 12 months of age (corrected age if born preterm)). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07212010.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.