NCT04976608

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

July 5, 2021

Last Update Submit

July 15, 2021

Conditions

Congenital Cataract

Keywords

amblyopiaMRISD-OCTvisual acuityretinal structurevisual cortex structure

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (3)

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

Eligibility Criteria

Age4 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Intraoperative and postoperative complications include glaucoma, retinal, corneal, or refractive medium diseases
  • Behavioral, cognitive impairment
  • Developmental delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 30854758BACKGROUND

  • 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.

    PMID: 29450539BACKGROUND

  • 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.

    PMID: 28539328BACKGROUND

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yune Zhao

    Ophthalmology and Optometry Hospital

    STUDY DIRECTOR

Central Study Contacts

Yune Zhao

CONTACT

8613819707056zyehzeye@126.com

Jiayan Fang

CONTACT

86159577933281132093186@qq.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 26, 2021

Study Start

June 16, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations

CN(1)