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Completed

NCT Number: NCT03865134

Evaluation of Visual - Motor Development in Children With Retinopathy of Prematurity

The aim of this study was to investigate the eye structure, visual impairment, visual motor development and motor coordination of children between 2-6 ages that had applied to diod laser photocoagulation and intravitreal anti - vascular endothelial growth factor treatment.

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Key information

Conditions

Premature Retinopathy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Motor Delay Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Disorders Retinal Diseases Retinopathy of Prematurity Sensation Disorders Signs and Symptoms Vision Disorders Visual Impairment

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

About this study

There are three different groups in this study. Children between 2-6 ages that had applied to diod laser photocoagulation and intravitreal anti - vascular endothelial growth factor treatment will have evaluated with Snellen Test, Titmus Fly Test, Optical Kohlerans Tomography, Beery-Buktenica Developmental Test of Visual Motor Integration, Peabody Developmental Motor Scales-II, World Health Organization Quality of Life - BREF and State - Trait Anxiety Inventory.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range between 2-6 years of age
  • Gestational age range 26-34. be between weeks
  • To be diagnosed with retinopathy of prematurity
  • Neurological, hereditary and not having metabolic disease
  • Compliance with visual examinations and physiotherapy evaluations
  • To be children and parents who agree to participate in the study

Exclusion criteria

  • To be a child who does not comply with Optical Kohlerans Tomography (OCT)
  • Not participating in one or more of the eye examination or physiotherapy assessments
  • Being children and parents who do not agree to participate in the study

Treatment and study plan

Snellen Test

Diagnostic Test

Visual acuity measurement

Autorefractometer

Diagnostic Test

Refraction measurement

Titmus Stereo Fly Test

Diagnostic Test

Stereopsis measurement

Optical Kohlerans Tomography

Diagnostic Test

Retinal development measurement

Investigation of Visual Motor Integration

Behavioral

Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.

Peabody Developmental Motor Scales - II

Behavioral

Evaluation of motor development

World Health Organization Quality of Life - BREF

Behavioral

Assesment of quality of life

State - Trait Anxiety Inventory

Behavioral

Assesment of anxiety

Primary outcomes

  1. Visual Motor Integration

    Time frame: 3 weeks

    Visual-motor integration (VMI) is "the degree to which visual perception and finger-hand movements are well coordinated" and will asses with Beery-Buktenica Developmental Test of Visual-Motor Integration in this study. This test is a standardized, norm-referenced assessment involving copying geometric forms that is used to determine the level of integration between visual and motor systems in people of all ages.

    The Short Format and Full Format tests take about 10-15 minutes each to administer. Results are reported as standard scores, percentiles, and age equivalents.

  2. Visual Perception

    Time frame: 3 weeks

    Visual perception will asses with Beery-Buktenica Developmental Test of Visual-Motor Integration in this study. This test is a standardized, norm-referenced assessment involving copying geometric forms that is used to determine the level of integration between visual and motor systems in people of all ages. Visual Perception test takes about 5 minutes. Results are reported as standard scores, percentiles, and age equivalents.

  3. Motor Coordination

    Time frame: 3 weeks

    Motor Coordination is coordination of finger movements and will asses by Beery-Buktenica Developmental Test of Visual-Motor Integration in this study. This test is a standardized, norm-referenced assessment involving copying geometric forms that is used to determine the level of integration between visual and motor systems in people of all ages. Motor coordination test takes about 5 minutes. Results are reported as standard scores, percentiles, and age equivalents.

  4. Retinal Layers' Development

    Time frame: 3 weeks

    Development of retinal layers will assess with Optical coherence tomography (OCT). The OCT allows for in vivo, cross-sectional assessment of eye tissue, including the retina and its vasculature. By comparing the interference patterns of light that passes through live tissue to a reference arm, OCT provides high-resolution imaging of just a few microns of eye microanatomy.

Other outcomes

  1. Quality of Life in Parents

    Time frame: 3 weeks

    Quality of life assessment of parents will evaluate with The WHOQOL-BREF instrument that is comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.

  2. State - Trait Anxiety of Parents

    Time frame: 3 weeks

    State and trait anxiety level of parents will asses by the State-Trait Anxiety Inventory (STAI) that is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress.The STAI has 20 items for assessing trait anxiety and 20 for state anxiety.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Evaluation of Visual - Motor Integration and Motor Coordination in Children With Retinopathy of Prematurity

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2019
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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