Tertiary Care for Visual Developmental Disorders in Pre-school Children

NCT03251456 | Completed DMC

• 1 other identifier: SYSU-OPH-002
• Study Type: interventional
• Target: 1,114
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Developmental Disorders

Keywords

myopia; Tertiary Care; Pre-school Children

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• The cost-effective of the tertiary care for visual developmental disorders

  6 months

Study Arms (2)

Tertiary care

EXPERIMENTAL

Other: Tertiary care

Usual care

ACTIVE COMPARATOR

Other: Usual Care

Interventions

Tertiary care 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.

Tertiary care

Usual Care 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.

Usual care

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Unwilling to sign the consent form
• Exiting eye diseases and already receiving therapies and follow up

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Yudu

Ganzhou, Jiangxi, 342300, China

Location

Related Publications (8)

• 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.

  PMID: 16043831 BACKGROUND

• 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.

  PMID: 27640004 BACKGROUND

• 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.

  PMID: 21282267 BACKGROUND

• 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.

  PMID: 15090409 BACKGROUND

• 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.

  PMID: 22108361 BACKGROUND

• 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.

  PMID: 23360915 BACKGROUND

• 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.

  PMID: 17299340 BACKGROUND

• 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.

  PMID: 32055790 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Tertiary Healthcare

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Yizhi LIU, MD,PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Yangfa ZENG, MD,Master

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor,director of Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 16, 2017
• Study Start: August 18, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)