Tertiary Care for Visual Developmental Disorders in Pre-school Children

NCT ID: NCT03251456

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-18
• Study Completion Date: 2018-06-30

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.

Conditions

Visual Developmental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tertiary care

Group Type: EXPERIMENTAL

Tertiary care

Intervention Type: OTHER

1. 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.

Usual care

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

1. 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.

Interventions

Tertiary care

1. 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.

Intervention Type: OTHER

Usual Care

1. 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients who are aged 4-7 years and of Chinese citizen

2. Who is willing to sign the consent form

3. 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

1. Unwilling to sign the consent form

2. Exiting eye diseases and already receiving therapies and follow up

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yizhi Liu

Clinical Professor,director of Zhongshan Ophthalmic Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yizhi LIU, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Yangfa ZENG, MD,Master

Role: STUDY_DIRECTOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Yudu

Ganzhou, Jiangxi, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 16043831 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27640004 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21282267 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15090409 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22108361 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23360915 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17299340 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32055790 (View on PubMed)

Other Identifiers

SYSU-OPH-002

Identifier Type: -

Identifier Source: org_study_id