Cataract;Macular ThicknessNCT02653794
The Variations of Macular Thickness in Juvenile Subjects
An observational study of Cataract;Macular Thickness, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Cataract;Macular Thickness
- How many people
- 364 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- age from 4 to 17 years
- children with the mild-to-moderate refraction error(from 0 to -6.00D)
Who cannot join
- children with visual complaints
Trial locations and contacts
1 site in 1 country.
China1 site
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: 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.
Read the 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).
- Conditions
- Cataract;Macular Thickness
- Keywords
- Juvenile Subjects'characteristics
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Macular thickness
MT measurement using SD-OCT(an imaging technique widely used in clinic in last twenty years)
Measured: 4 to 17 years after birth
change of axis length measurement using an IOLMaster
axis length measurement using an IOLMaster
Measured: 4 to 17 years after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cataract;Macular ThicknessStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Erping Long, Sun Yat-sen University
- Investigators
- Erping Long, M.D.,Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D.;Ph.D., Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityHaotian Lin, M.D.;Ph.D., Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653794
- Sponsor's protocol ID
- CCPMOH2016-China1
- Status last verified
- Apr 2016
- First submitted
- 10 Jan 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15848921Wakitani 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.
PubMed 12707596Chen 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.
PubMed 25316719Lim 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.
PubMed 15728555
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Variations of Macular Thickness in Juvenile Subjects With Mild-to-Moderate Refractive Error
- ClinicalTrials.gov ID
- NCT02653794
- Acronym / sponsor ID
- CCPMOH2016-China1
- Conditions
- Cataract;Macular Thickness
- Keywords
- Juvenile Subjects'characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- age from 4 to 17 years
- children with the mild-to-moderate refraction error(from 0 to -6.00D)
Key exclusion criteria (1 listed)
- children with visual complaints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change of Macular thickness
Time frame: 4 to 17 years after birth
MT measurement using SD-OCT(an imaging technique widely used in clinic in last twenty years)
change of axis length measurement using an IOLMaster
Time frame: 4 to 17 years after birth
axis length measurement using an IOLMaster
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Background: PubMed 15848921Ojaimi 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.
- Background: PubMed 12707596Wakitani 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.
- Background: PubMed 25316719Chen 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.
- Background: PubMed 15728555Lim 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.
- Description Home page of Zhongshan Ophthalmic CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erping Long, M.D.,Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D.;Ph.D. study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Haotian Lin, M.D.;Ph.D. study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract;Macular Thickness, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Macular thickness (time frame: 4 to 17 years after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653794, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.