Tertiary Care for Visual Developmental Disorders in Pre-school Children
Primary Purpose
Visual Developmental Disorders
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tertiary care
Usual Care
Sponsored by
About this trial
This is an interventional prevention trial for Visual Developmental Disorders focused on measuring myopia, Tertiary Care, Pre-school Children
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unwilling to sign the consent form
- Exiting eye diseases and already receiving therapies and follow up
Sites / Locations
- Yudu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tertiary care
Usual care
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03251456
First Posted
August 10, 2017
Last Updated
June 18, 2019
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03251456
Brief Title
Tertiary Care for Visual Developmental Disorders in Pre-school Children
Official Title
Tertiary Care Based Visual Developmental Diseases Management Model Among Preschool Children in China: a Cluster Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Developmental Disorders
Keywords
myopia, Tertiary Care, Pre-school Children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tertiary care
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Tertiary care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
The consultation rate in six month after the parents receiving the visual screening report
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The cost-effective of the tertiary care for visual developmental disorders
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Unwilling to sign the consent form
Exiting eye diseases and already receiving therapies and follow up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi LIU, MD,PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yangfa ZENG, MD,Master
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Yudu
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
342300
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16043831
Citation
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.
Results Reference
background
PubMed Identifier
27640004
Citation
Hendler 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.
Results Reference
background
PubMed Identifier
21282267
Citation
US 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.
Results Reference
background
PubMed Identifier
15090409
Citation
Konig 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.
Results Reference
background
PubMed Identifier
22108361
Citation
Kemper 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.
Results Reference
background
PubMed Identifier
23360915
Citation
Donahue 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.
Results Reference
background
PubMed Identifier
17299340
Citation
Donahue SP. Prescribing spectacles in children: a pediatric ophthalmologist's approach. Optom Vis Sci. 2007 Feb;84(2):110-4. doi: 10.1097/OPX.0b013e318031b09b.
Results Reference
background
PubMed Identifier
32055790
Citation
Zeng 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.
Results Reference
derived
Learn more about this trial
Tertiary Care for Visual Developmental Disorders in Pre-school Children
We'll reach out to this number within 24 hrs