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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04976608
Other study ID # amblyopia-LZL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 16, 2021
Est. completion date December 30, 2021

Study information

Verified date July 2021
Source Wenzhou Medical University
Contact Yune Zhao
Phone 8613819707056
Email zyehzeye@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the influence of the visual acuity after congenital surgery on the retinal and visual cortex structure.


Description:

According to the visual acuity after congenital cataract surgery, 30 patients are divided into 3 groups.SD-OCT and MRI were used to measure the parameters of the retina and the visual cortex, to compare the differences between different groups, and to analyze the relationship between the structure of the retina and the visual cortex and visual acuity.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 4 Years to 60 Years
Eligibility Inclusion Criteria: - age of 4-60 years - Congenital cataract surgery is planned - The operation was successful without any complications - Can cooperate well with OCT and MRI examinations Exclusion Criteria: - Intraoperative and postoperative complications include glaucoma, retinal, corneal, or refractive medium diseases - Behavioral, cognitive impairment - Developmental delay

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Eye Hospital of Wenzhou Medical College Wenzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Allen B, Schmitt MA, Kushner BJ, Rokers B. Retinothalamic White Matter Abnormalities in Amblyopia. Invest Ophthalmol Vis Sci. 2018 Feb 1;59(2):921-929. doi: 10.1167/iovs.17-22930. — View Citation

Long E, Zhang X, Liu Z, Wu X, Tan X, Lin D, Cao Q, Chen J, Lin Z, Wang D, Li X, Li J, Wang J, Li W, Lin H, Chen W, Liu Y. Dynamic response to initial stage blindness in visual system development. Clin Sci (Lond). 2017 Jun 28;131(13):1515-1527. doi: 10.1042/CS20170234. Print 2017 Jul 1. — View Citation

Lu L, Li Q, Zhang L, Tang S, Yang X, Liu L, Sweeney JA, Gong Q, Huang X. Altered cortical morphology of visual cortex in adults with monocular amblyopia. J Magn Reson Imaging. 2019 Nov;50(5):1405-1412. doi: 10.1002/jmri.26708. Epub 2019 Mar 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Macular thickness Scan the 3.0mm diameter ETDRS ring area in the macular area with SD-OCT. 2021.12.30
Primary Subfoveal choroidal thickness Scan the Subfoveal choroid in enhanced scan mode with SD-OCT. 2021.12.30
Primary Retinal nerve fiber layer thickness Scan concentric circles with a length of 3.4mm and a diameter ranging from 2.5mm to 4.0mm in 12 directions centered on the optic disc with SD-OCT. 2021.12.30
Primary The volume of the lateral geniculate body Measure the volume of the lateral geniculate body by T1 phase scan of MRI 2021.12.30
Primary The volume of the brodmann 17,18,19 area Masure the volume of the brodmann 17,18,19 area by T1 phase scan of MRI 2021.12.30
Primary The FA of the white matter fiber bundle Measure the Fraction Anisotropy of the white matter fiber bundle related to visual signal transduction by DWI scan of MRI 2021.12.30
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