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

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

Study Overview

• Status: Recruiting
• Conditions: Congenital Cataract

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Jiayan Fang; Phone Number: 8615957793328; Email: 1132093186@qq.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Recruiting
      • Eye Hospital of Wenzhou Medical College
      • Contact: zhangliang LI; Phone Number: 13968832833; Email: lizhangliang0328@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with congenital cataract and were informed about their inclusion in the study and provided written consent.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group 1; The BCVA of eyes is greater than 0.6
Group 2; The BCVA of eyes is from 0.1 to 0.6
Group 3; The BCVA of eyes is less than 0.6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular thickness	Scan the 3.0mm diameter ETDRS ring area in the macular area with SD-OCT.	2021.12.30
Subfoveal choroidal thickness	Scan the Subfoveal choroid in enhanced scan mode with SD-OCT.	2021.12.30
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
The volume of the lateral geniculate body	Measure the volume of the lateral geniculate body by T1 phase scan of MRI	2021.12.30
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
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

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: MRI; visual acuity; amblyopia; SD-OCT; retinal structure; visual cortex structure
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: amblyopia-LZL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No