Evaluation of Visual - Motor Development in Children With Retinopathy of Prematurity
March 13, 2020 updated by: Istanbul Medipol University Hospital
Evaluation of Visual - Motor Integration and Motor Coordination 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Diagnostic test: Snellen Test
- Diagnostic test: Autorefractometer
- Diagnostic test: Titmus Stereo Fly Test
- Diagnostic test: Optical Kohlerans Tomography
- Behavioral: Investigation of Visual Motor Integration
- Behavioral: Peabody Developmental Motor Scales - II
- Behavioral: World Health Organization Quality of Life - BREF
- Behavioral: State - Trait Anxiety Inventory
Detailed 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.
Study Type
Observational
Enrollment (Actual)
69
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beykoz
-
Istanbul, Beykoz, Turkey
- Istanbul Medipol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 6 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants who were followed up and treated in the outpatient clinic of Zeynep Kamil Women and Children Diseases Training and Research Hospital, Ophthalmology Clinic with the diagnosis of Prematurity Retinopathy between the years 2012-2015 were included in the study.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Laser Group
Children with premature retinopathy treated with Laser therapy.
All cases are evaluated with Snellen Test, Autorefractometer, Titmus Stereo Fly Test, Optical Kohlerans Tomography, Peabody Developmental Motor Scales - II.
Investigation of Visual Motor Integration will evaluate with Beery- Buktenica Developmental Test of Visual Motor Integration and Peabody.
Parents are evaluated World Health Organization Quality of Life - BREF and State - Trait Anxiety Inventory.
|
Visual acuity measurement
Refraction measurement
Stereopsis measurement
Retinal development measurement
Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.
Evaluation of motor development
Assesment of quality of life
Assesment of anxiety
|
|
Anti-VEGF Group
Children with premature retinopathy treated with anti-VEGF therapy.
All cases are evaluated with Snellen Test, Autorefractometer, Titmus Stereo Fly Test, Optical Kohlerans Tomography, Peabody Developmental Motor Scales - II.
Investigation of Visual Motor Integration will evaluate with Beery- Buktenica Developmental Test of Visual Motor Integration and Peabody.
Parents are evaluated World Health Organization Quality of Life - BREF and State - Trait Anxiety Inventory.
|
Visual acuity measurement
Refraction measurement
Stereopsis measurement
Retinal development measurement
Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.
Evaluation of motor development
Assesment of quality of life
Assesment of anxiety
|
|
Regrese Group
Children with premature retinopathy haven't applied any invasive treatment method.
All cases are evaluated with Snellen Test, Autorefractometer, Titmus Stereo Fly Test, Optical Kohlerans Tomography, Peabody Developmental Motor Scales - II.
Investigation of Visual Motor Integration will evaluate with Beery- Buktenica Developmental Test of Visual Motor Integration and Peabody.
Parents are evaluated World Health Organization Quality of Life - BREF and State - Trait Anxiety Inventory.
|
Visual acuity measurement
Refraction measurement
Stereopsis measurement
Retinal development measurement
Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.
Evaluation of motor development
Assesment of quality of life
Assesment of anxiety
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
3 weeks
|
|
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 weeks
|
|
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.
|
3 weeks
|
|
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.
|
3 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 weeks
|
|
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.
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Zeliha Candan Algun, Istanbul Medipol University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Kabatas EU, Kurtul BE, Altiaylik Ozer 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.
- 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 Res. 2015 May;40(6):585-91. doi: 10.3109/02713683.2014.941070. Epub 2014 Jul 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 20, 2018
Primary Completion (ACTUAL)
March 25, 2019
Study Completion (ACTUAL)
April 25, 2019
Study Registration Dates
First Submitted
March 1, 2019
First Submitted That Met QC Criteria
March 5, 2019
First Posted (ACTUAL)
March 6, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 16, 2020
Last Update Submitted That Met QC Criteria
March 13, 2020
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01-E.34158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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