The Variations of Macular Thickness in Juvenile Subjects

The Variations of Macular Thickness in Juvenile Subjects With Mild-to-Moderate Refractive Error

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.

Study Overview

• Status: Completed
• Conditions: Cataract;Macular Thickness

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).

• Study Type: Observational
• Enrollment (Actual): 364

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhognshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Ministry of Health, China
• Investigators: Study Chair: Yizhi Liu, M.D.;Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University; Principal Investigator: Erping Long, M.D.,Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University; Study Director: Haotian Lin, M.D.;Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Description Home page of Zhongshan Ophthalmic Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 10, 2016
• First Submitted That Met QC Criteria: January 10, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Juvenile Subjects'characteristics
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CCPMOH2016-China1