NCT02653794

Brief Summary

It is reported that it takes a period form 22 weeks pregnant to the first 45 months of life for macular region to develop from structural formation to functional integrity. However, children are still in the critical period of plastic visual development, for their visual acuity has not yet reached the level of adults. Similarly macular retinal structure may develop with age. It is very important to study in macular thickness of this period and to have a proper cognition of it and the relation between macular thickness and other ocular parameter for the research of retinal development and diseases and the early screen of fundus diseases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

January 10, 2016

Last Update Submit

April 12, 2016

Conditions

Cataract;Macular Thickness

Keywords

Juvenile Subjects'characteristics

Outcome Measures

Primary Outcomes (2)

  • change of Macular thickness

    MT measurement using SD-OCT(an imaging technique widely used in clinic in last twenty years)

    4 to 17 years after birth

  • change of axis length measurement using an IOLMaster

    axis length measurement using an IOLMaster

    4 to 17 years after birth

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Subjects consisted of Zhongshan Ophthalmic Center (ZOC) and Hualong Primary School (HPS)), who came from ZOC group were mild-to-moderate refraction error while who come from HPS group had no visual complaints.

You may qualify if:

  • age from 4 to 17 years
  • children with the mild-to-moderate refraction error(from 0 to -6.00D)

You may not qualify if:

  • children with visual complaints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (4)

  • Ojaimi E, Rose KA, Smith W, Morgan IG, Martin FJ, Mitchell P. Methods for a population-based study of myopia and other eye conditions in school children: the Sydney Myopia Study. Ophthalmic Epidemiol. 2005 Feb;12(1):59-69. doi: 10.1080/09286580490921296.

    PMID: 15848921BACKGROUND

  • Wakitani Y, Sasoh M, Sugimoto M, Ito Y, Ido M, Uji Y. Macular thickness measurements in healthy subjects with different axial lengths using optical coherence tomography. Retina. 2003 Apr;23(2):177-82. doi: 10.1097/00006982-200304000-00007.

    PMID: 12707596BACKGROUND

  • Chen S, Wang B, Dong N, Ren X, Zhang T, Xiao L. Macular measurements using spectral-domain optical coherence tomography in Chinese myopic children. Invest Ophthalmol Vis Sci. 2014 Oct 14;55(11):7410-6. doi: 10.1167/iovs.14-13894.

    PMID: 25316719BACKGROUND

  • Lim MC, Hoh ST, Foster PJ, Lim TH, Chew SJ, Seah SK, Aung T. Use of optical coherence tomography to assess variations in macular retinal thickness in myopia. Invest Ophthalmol Vis Sci. 2005 Mar;46(3):974-8. doi: 10.1167/iovs.04-0828.

    PMID: 15728555BACKGROUND

Related Links

Study Officials

  • Erping Long, M.D.,Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Yizhi Liu, M.D.;Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

  • Haotian Lin, M.D.;Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor,Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

January 10, 2016

First Posted

January 12, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations

CN(1)