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

Visual Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03865134
• Other study ID #: 10840098-604.01.01-E.34158
• Status: Completed
• Start date: September 20, 2018
• Est. completion date: April 25, 2019

Study information

• Verified date: February 2019
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: April 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Motor Delay
• Premature Retinopathy
• Retinal Diseases
• Retinopathy of Prematurity
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Diagnostic Test:
• Snellen Test
Visual acuity measurement
• Autorefractometer
Refraction measurement
• Titmus Stereo Fly Test
Stereopsis measurement
• Optical Kohlerans Tomography
Retinal development measurement

Behavioral:
• Investigation of Visual Motor Integration
Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.
• Peabody Developmental Motor Scales - II
Evaluation of motor development
• World Health Organization Quality of Life - BREF
Assesment of quality of life
• State - Trait Anxiety Inventory
Assesment of anxiety

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul	Beykoz

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Araz-Ersan B, Kir N, Tuncer S, Aydinoglu-Candan O, Yildiz-Inec D, Akdogan B, Ekici B, Demirel A, Ozmen M. Preliminary anatomical and neurodevelopmental outcomes of intravitreal bevacizumab as adjunctive treatment for retinopathy of prematurity. Curr Eye R — View Citation

Kabatas EU, Kurtul BE, Altiaylik Özer P, Kabatas N. Comparison of Intravitreal Bevacizumab, Intravitreal Ranibizumab and Laser Photocoagulation for Treatment of Type 1 Retinopathy of Prematurity in Turkish Preterm Children. Curr Eye Res. 2017 Jul;42(7):1054-1058. doi: 10.1080/02713683.2016.1264607. Epub 2017 Jan 27. — View Citation

Rothman AL, Mangalesh S, Chen X, Toth CA. Optical coherence tomography of the preterm eye: from retinopathy of prematurity to brain development. Eye Brain. 2016 May 27;8:123-133. doi: 10.2147/EB.S97660. eCollection 2016. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life in Parents	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.	3 weeks
Other	State - Trait Anxiety of Parents	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.	3 weeks
Primary	Visual Motor Integration	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.	3 weeks
Primary	Visual Perception	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 weeks
Primary	Motor Coordination	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.	3 weeks
Primary	Retinal Layers' Development	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.	3 weeks