Clinical trial NCT04976608: Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery
Official title: Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Cataract
Keywords: amblyopia
MRI
SD-OCT
visual acuity
retinal structure
visual cortex structure
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with congenital cataract and were informed about their inclusion in the study and provided written consent.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Macular thickness
timeFrame: 2021.12.30
measure: Subfoveal choroidal thickness
timeFrame: 2021.12.30
measure: Retinal nerve fiber layer thickness
timeFrame: 2021.12.30
measure: The volume of the lateral geniculate body
timeFrame: 2021.12.30
measure: The volume of the brodmann 17,18,19 area
timeFrame: 2021.12.30
measure: The FA of the white matter fiber bundle
timeFrame: 2021.12.30
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Ophthalmology and Optometry Hospital
name: Yune Zhao
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.