NCT04824963

Brief Summary

The ocular biometric parameters of the children with congenital cataract including preoperative pupil diameter, corneal diameter, axial length, anterior and posterior capsule size, iris adhesion. And then analysis whether the preoperative parameters were correlated with the implantation site of secondary implantation.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 23, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 27, 2021

Last Update Submit

June 22, 2021

Conditions

Congenital Cataract

Keywords

secondary implantationciliary sulcus

Outcome Measures

Primary Outcomes (2)

  • pupil diameter

    preoperative pupil diameter size

    Before lens implantation

  • posterior capsule diameter

    preoperative posterior capsule diameter size

    Before lens implantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Congenital cataract patient accepted secondary IOLs implantation at Eye hospital of Wenzhou Medical University.

You may qualify if:

  • Patients were diagnosed as congenital cataract without lens after surgery
  • Secondare IOLs implantation surgery was performed in Eye hospital of Wenzhou Medical University

You may not qualify if:

  • Suffers from uveitis, glaucoma and other ocular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

RECRUITING

Study Officials

  • Yune Zhao

    Ophthalmology and Optometry Hospital

    STUDY DIRECTOR

Central Study Contacts

Yune Zhao

CONTACT

+86 13819707056zyehzeye@126.com

Ziyi Lu

CONTACT

+86 15157759880937491851@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

March 27, 2021

First Posted

April 1, 2021

Study Start

March 27, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

June 23, 2021

Record last verified: 2021-03

Locations

CN(1)