Premature RetinopathyNCT03865134
Evaluation of Visual - Motor Development in Children With Retinopathy of Prematurity
An observational study of Premature Retinopathy and Visual Impairment, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Retinopathy, Visual Impairment, Motor Delay
- What is being tested?
- Snellen Test, Autorefractometer and Titmus Stereo Fly Test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2018to 25 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Premature Retinopathy, Visual Impairment, Motor Delay
- Being tested
- Snellen Test, Autorefractometer, Titmus Stereo Fly Test, Optical Kohlerans Tomography, Investigation of Visual Motor Integration
- Medical subject headings
- Retinopathy of Prematurity, Vision Disorders, Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snellen TestDiagnostic test
Visual acuity measurement
AutorefractometerDiagnostic test
Refraction measurement
Titmus Stereo Fly TestDiagnostic test
Stereopsis measurement
Optical Kohlerans TomographyDiagnostic test
Retinal development measurement
Investigation of Visual Motor IntegrationBehavioural
Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.
Peabody Developmental Motor Scales - IIBehavioural
Evaluation of motor development
World Health Organization Quality of Life - BREFBehavioural
Assesment of quality of life
State - Trait Anxiety InventoryBehavioural
Assesment of anxiety
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 | |
| 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. Receives: 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 | |
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start20 Sep 2018
- Primary completion25 Mar 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature RetinopathyStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeliha Candan Algun, Study director, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865134
- Sponsor's protocol ID
- 10840098-604.01.01-E.34158
- Status last verified
- Feb 2019
- First submitted
- 1 Mar 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28539807Kabatas 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.
PubMed 28128986Araz-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.
PubMed 25025864
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual - Motor Integration and Motor Coordination in Children With Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT03865134
- Acronym / sponsor ID
- 10840098-604.01.01-E.34158
- Conditions
- Premature Retinopathy, Visual Impairment, Motor Delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 6 Mar 2019 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser Group | – | 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 InventoryChildren 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. |
| Anti-VEGF Group | – | 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 InventoryChildren 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. |
| Regrese Group | – | 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 InventoryChildren 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snellen TestVisual acuity measurement | Diagnostic test | Anti-VEGF Group, Laser Group, Regrese Group |
| AutorefractometerRefraction measurement | Diagnostic test | Anti-VEGF Group, Laser Group, Regrese Group |
| Titmus Stereo Fly TestStereopsis measurement | Diagnostic test | Anti-VEGF Group, Laser Group, Regrese Group |
| Optical Kohlerans TomographyRetinal development measurement | Diagnostic test | Anti-VEGF Group, Laser Group, Regrese Group |
| Investigation of Visual Motor IntegrationInvestigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration. | Behavioural | Anti-VEGF Group, Laser Group, Regrese Group |
| Peabody Developmental Motor Scales - IIEvaluation of motor development | Behavioural | Anti-VEGF Group, Laser Group, Regrese Group |
| World Health Organization Quality of Life - BREFAssesment of quality of life | Behavioural | Anti-VEGF Group, Laser Group, Regrese Group |
| State - Trait Anxiety InventoryAssesment of anxiety | Behavioural | Anti-VEGF Group, Laser Group, Regrese Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: PubMed 28539807Rothman 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.
- Background: PubMed 28128986Kabatas 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.
- Results publication: PubMed 25025864Araz-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.
- 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. This study is not recruiting at the moment.
Zeliha Candan Algun study director
Istanbul Medipol University Hospital
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 Premature Retinopathy and Visual Impairment, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 16 Mar 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Motor Integration (time frame: 3 weeks). The study lists 4 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 NCT03865134, which also lists 3 linked publications.
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 16 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.