Clinical trial NCT02653794: The Variations of Macular Thickness in Juvenile Subjects
Official title: The Variations of Macular Thickness in Juvenile Subjects With Mild-to-Moderate Refractive Error
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract;Macular Thickness
Keywords: Juvenile Subjects'characteristics
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
First posted: 2016-01-12
Enrollment: 364
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_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.

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.

Detailed description: 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.

Optical Coherence Tomography (OCT) is an imaging technique widely used in clinic in last twenty years. According to the base theory of dim coherent light interference machine, OCT detect the back-reflection or scattering signal of biological tissue to the incident dim coherent light, and acquire the two-dimension or three- dimension image of biological tissue by scan. It enables the characteristic of tissue's microstructure in vivo and makes it possible to observe dynamically developing process of diseases so that it has become an essential test for macular and optic nerve diseases with unmatched measurement reproducibility. It also enables high-resolution and noninvasive imaging of the retinal lamina, the organizational structure of macular. It is most often used clinically to demonstrate the macular morphology, treatment response and disease progression clinically. However, who researchers studyed in through OCT were mostly patients with retinal disease and adults. There was few study focused on OCT's application to children.

In this study, the investigators aims to measure macular thickness (MT) using spectral-domain optical coherence tomography (SD-OCT) and to investigate MT variations with sex, age, laterality, refraction error (RE) and axial length (AL).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* children with visual complaints

Primary outcomes:
measure: change of Macular thickness
timeFrame: 4 to 17 years after birth
measure: change of axis length measurement using an IOLMaster
timeFrame: 4 to 17 years after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Erping Long, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D.;Ph.D.
role: STUDY_CHAIR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D.;Ph.D.
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.