Visual Developmental DisordersNCT03251456
Tertiary Care for Visual Developmental Disorders in Pre-school Children
A study testing Tertiary care in people with Visual Developmental Disorders, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Visual development disorders are major public health problems among children especially in China. How to find an effective and economic way to manage the larger number of children in China remains exploring. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Developmental Disorders
- What is being tested?
- Tertiary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,114 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2017to 30 Jun 2018
- Phase
- Interventional
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who are aged 4-7 years and of Chinese citizen
- Who is willing to sign the consent form
- Children at the kindergarten will receiving the eye diseases screening of public health equalization programs in China, and there are abnormal findings after screening
Who cannot join
- Unwilling to sign the consent form
- Exiting eye diseases and already receiving therapies and follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tertiary Care Based Visual Developmental Diseases Management Model Among Preschool Children in China: a Cluster Randomized Controlled Trial
Visual development disorders are major public health problems among children especially in China. How to find an effective and economic way to manage the larger number of children in China remains exploring. The national basic public health services of China offer visual acuity screening for preschool children for free every year. The aim of this study is to demonstrate the feasibility, cost-effective and the influence factors of compliance of tertiary care for visual developmental disorders in pre-school children after screening, and whether this disease management model is more effective and superior than the current medical care in china.
Read the detailed description
Visual development disorders including amblyopia , strabismus ,refractive error are an important public health problem among children, and the visual impairment caused by visual development disorders is lifelong and can be profound. Timely discovering and treatment of visual development disorders are significant for the recovering of visual function in children. The national basic public health services of China offer the basic visual acuity screening every year for free. In this study, the investigators try to explore the cost-effective and compliance of the national basic public health services based tertiary care model for the management of visual development disorders among preschool children. This Tertiary care based on disease management model among preschool children was conducted at Yudu county, Jiangxi province, in China. Preschool vision screening relied on the national basic public health services of China (refractive errors examined by the Retinomax autorefractor). Children who failed the screening were randomized into two groups, the intervention group: their parents will be informed and transferred to an ophthalmologist and optometrist at Ophthalmic Referral Center, receiving basic eye examination and therapy (visual corrected by glasses and periodic review); The control group: their parents will be informed and suggest them to take their children to the hospital for further examination by themselves.
- Conditions
- Visual Developmental Disorders
- Being tested
- Tertiary care, Usual Care
- Keywords
- myopia, Tertiary Care, Pre-school Children
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tertiary careOther
- Inform the parents that there are abnormalities after eye disease screening of their children, and the program of tertiary care for visual developmental disorders
- The children will be receiving the appropriate therapy in tertiary care and follow-up according to the clinical guidelines
- Six months after receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary.
Usual CareOther
- Inform the parents that there are abnormalities after eye disease screening of their children
- Inform the parents that they should take their children to the hospital for further consultation
- Six months after the receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Tertiary care | Experimental | Not described Receives: Other: Tertiary care |
| Usual care | Active comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The consultation rate in six month after the parents receiving the visual screening report
The consultation rate will be determined by the number of children who had visual screening abnormal actually go to hospital for consultation by telephone follow-up.
Measured: 6 months
Secondary outcomes (1)
The cost-effective of the tertiary care for visual developmental disorders
The cost of the disease management model will be determined by the cost per child when receiving the therapy including the travelling and medical fee, and the time they spent. And the clinical efficacy of the tertiary care for visual developmental disorders will be determined by whether or not the child receiving the appropriate therapy according to the clinical guideline.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start18 Aug 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Visual Developmental DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Yizhi LIU, MD,PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYangfa ZENG, MD,Master, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251456
- Sponsor's protocol ID
- SYSU-OPH-002
- Status last verified
- Jun 2019
- First submitted
- 10 Aug 2017
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vision in Preschoolers Study Group. Preschool vision screening tests administered by nurse screeners compared with lay screeners in the vision in preschoolers study. Invest Ophthalmol Vis Sci. 2005 Aug;46(8):2639-48. doi: 10.1167/iovs.05-0141.
PubMed 16043831Hendler K, Mehravaran S, Lu X, Brown SI, Mondino BJ, Coleman AL. Refractive Errors and Amblyopia in the UCLA Preschool Vision Program; First Year Results. Am J Ophthalmol. 2016 Dec;172:80-86. doi: 10.1016/j.ajo.2016.09.010. Epub 2016 Sep 14.
PubMed 27640004US Preventive Services Task Force. Vision screening for children 1 to 5 years of age: US Preventive Services Task Force Recommendation statement. Pediatrics. 2011 Feb;127(2):340-6. doi: 10.1542/peds.2010-3177. Epub 2011 Jan 31.
PubMed 21282267Konig HH, Barry JC. Cost effectiveness of treatment for amblyopia: an analysis based on a probabilistic Markov model. Br J Ophthalmol. 2004 May;88(5):606-12. doi: 10.1136/bjo.2003.028712.
PubMed 15090409Kemper AR, Wallace DK, Patel N, Crews JE. Preschool vision testing by health providers in the United States: findings from the 2006-2007 Medical Expenditure Panel Survey. J AAPOS. 2011 Oct;15(5):480-3. doi: 10.1016/j.jaapos.2011.07.007.
PubMed 22108361Donahue SP, Arthur B, Neely DE, Arnold RW, Silbert D, Ruben JB; POS Vision Screening Committee. Guidelines for automated preschool vision screening: a 10-year, evidence-based update. J AAPOS. 2013 Feb;17(1):4-8. doi: 10.1016/j.jaapos.2012.09.012. Epub 2013 Jan 27.
PubMed 23360915Donahue SP. Prescribing spectacles in children: a pediatric ophthalmologist's approach. Optom Vis Sci. 2007 Feb;84(2):110-4. doi: 10.1097/OPX.0b013e318031b09b.
PubMed 17299340Zeng Y, Han X, Wang D, Chen S, Zheng Y, Jiang Y, Chen X, Li Y, Jin L, Chen Q, Liang X, Zhang X, Congdon N, Liu Y. Effect of a complex intervention to improve post-vision screening referral compliance among pre-school children in China: A cluster randomized clinical trial. EClinicalMedicine. 2020 Feb 4;19:100258. doi: 10.1016/j.eclinm.2020.100258. eCollection 2020 Feb.
PubMed 32055790
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tertiary Care Based Visual Developmental Diseases Management Model Among Preschool Children in China: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03251456
- Acronym / sponsor ID
- SYSU-OPH-002
- Conditions
- Visual Developmental Disorders
- Keywords
- myopia, Tertiary Care, Pre-school Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,114 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Aug 2017 (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.
Visual development disorders are major public health problems among children especially in China. How to find an effective and economic way to manage the larger number of children in China remains exploring. The national basic public health services of China offer visual acuity screening for preschool children for free every year. The aim of this study is to demonstrate the feasibility, cost-effective and the influence factors of compliance of tertiary care for visual developmental disorders in pre-school children after screening, and whether this disease management model is more effective and superior than the current medical care in china.
Detailed description
Visual development disorders including amblyopia , strabismus ,refractive error are an important public health problem among children, and the visual impairment caused by visual development disorders is lifelong and can be profound. Timely discovering and treatment of visual development disorders are significant for the recovering of visual function in children. The national basic public health services of China offer the basic visual acuity screening every year for free. In this study, the investigators try to explore the cost-effective and compliance of the national basic public health services based tertiary care model for the management of visual development disorders among preschool children. This Tertiary care based on disease management model among preschool children was conducted at Yudu county, Jiangxi province, in China. Preschool vision screening relied on the national basic public health services of China (refractive errors examined by the Retinomax autorefractor). Children who failed the screening were randomized into two groups, the intervention group: their parents will be informed and transferred to an ophthalmologist and optometrist at Ophthalmic Referral Center, receiving basic eye examination and therapy (visual corrected by glasses and periodic review); The control group: their parents will be informed and suggest them to take their children to the hospital for further examination by themselves.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tertiary care | Experimental | Other: Tertiary care |
| Usual care | Active comparator | Other: Usual Care |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients who are aged 4-7 years and of Chinese citizen
- Who is willing to sign the consent form
- Children at the kindergarten will receiving the eye diseases screening of public health equalization programs in China, and there are abnormal findings after screening
Key exclusion criteria (2 listed)
- Unwilling to sign the consent form
- Exiting eye diseases and already receiving therapies and follow up
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 |
|---|---|---|
| Tertiary care1. Inform the parents that there are abnormalities after eye disease screening of their children, and the program of tertiary care for visual developmental disorders 2. The children will be receiving the appropriate therapy in tertiary care and follow-up according to the clinical guidelines 3. Six months after receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary. | Other | Tertiary care |
| Usual Care1. Inform the parents that there are abnormalities after eye disease screening of their children 2. Inform the parents that they should take their children to the hospital for further consultation 3. Six months after the receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary. | Other | Usual care |
Primary outcome
The consultation rate in six month after the parents receiving the visual screening report
Time frame: 6 months
The consultation rate will be determined by the number of children who had visual screening abnormal actually go to hospital for consultation by telephone follow-up.
1 secondary outcome
The cost-effective of the tertiary care for visual developmental disorders
Time frame: 6 months
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 20 Jun 2019.
- Background: PubMed 16043831Vision in Preschoolers Study Group. Preschool vision screening tests administered by nurse screeners compared with lay screeners in the vision in preschoolers study. Invest Ophthalmol Vis Sci. 2005 Aug;46(8):2639-48. doi: 10.1167/iovs.05-0141.
- Background: PubMed 27640004Hendler K, Mehravaran S, Lu X, Brown SI, Mondino BJ, Coleman AL. Refractive Errors and Amblyopia in the UCLA Preschool Vision Program; First Year Results. Am J Ophthalmol. 2016 Dec;172:80-86. doi: 10.1016/j.ajo.2016.09.010. Epub 2016 Sep 14.
- Background: PubMed 21282267US Preventive Services Task Force. Vision screening for children 1 to 5 years of age: US Preventive Services Task Force Recommendation statement. Pediatrics. 2011 Feb;127(2):340-6. doi: 10.1542/peds.2010-3177. Epub 2011 Jan 31.
- Background: PubMed 15090409Konig HH, Barry JC. Cost effectiveness of treatment for amblyopia: an analysis based on a probabilistic Markov model. Br J Ophthalmol. 2004 May;88(5):606-12. doi: 10.1136/bjo.2003.028712.
- Background: PubMed 22108361Kemper AR, Wallace DK, Patel N, Crews JE. Preschool vision testing by health providers in the United States: findings from the 2006-2007 Medical Expenditure Panel Survey. J AAPOS. 2011 Oct;15(5):480-3. doi: 10.1016/j.jaapos.2011.07.007.
- Background: PubMed 23360915Donahue SP, Arthur B, Neely DE, Arnold RW, Silbert D, Ruben JB; POS Vision Screening Committee. Guidelines for automated preschool vision screening: a 10-year, evidence-based update. J AAPOS. 2013 Feb;17(1):4-8. doi: 10.1016/j.jaapos.2012.09.012. Epub 2013 Jan 27.
- Background: PubMed 17299340Donahue SP. Prescribing spectacles in children: a pediatric ophthalmologist's approach. Optom Vis Sci. 2007 Feb;84(2):110-4. doi: 10.1097/OPX.0b013e318031b09b.
- Derived from this study: PubMed 32055790Zeng Y, Han X, Wang D, Chen S, Zheng Y, Jiang Y, Chen X, Li Y, Jin L, Chen Q, Liang X, Zhang X, Congdon N, Liu Y. Effect of a complex intervention to improve post-vision screening referral compliance among pre-school children in China: A cluster randomized clinical trial. EClinicalMedicine. 2020 Feb 4;19:100258. doi: 10.1016/j.eclinm.2020.100258. eCollection 2020 Feb.
- Individual participant dataSharing planned: No
Related trials for Visual Developmental Disorders
Not yet recruiting
joyVision: The Superiority of Co-design in the Development of a Serious Game for Children With Cerebral Visual Impairment
Cerebral Visual Impairment
Not yet recruiting
Effectiveness of Interactive Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children
Autism Disorder, Autism Spectrum Disorder (ASD
Not yet recruiting
Pilot Evaluation of the Developed Syntactic-Semantic Visual Configuration Intervention for Children With Language Impairment
Language Impairment, Autism
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Not yet recruiting
Body Image, Identity Development, and Social Media Use Among Youth With Visual Impairment: A Single Case Intervention Study
Visual Impairment, Cerebral Visual Impairment
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.
Yizhi LIU, MD,PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yangfa ZENG, MD,Master study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tertiary care in people with Visual Developmental Disorders, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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 3 inclusion and 2 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 20 Jun 2019. 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 China. 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?
The consultation rate in six month after the parents receiving the visual screening report (time frame: 6 months). 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 NCT03251456, which also lists 8 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 20 Jun 2019.