Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery

Congenital Cataract Clinical Trial

Official title:

Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976608
• Other study ID #: amblyopia-LZL
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract

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