NCT04441268

Brief Summary

The purpose of prospective cohort study is to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract(CC) and to explore key factors associated with the rate of change.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
335

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

10 years

First QC Date

June 19, 2020

Last Update Submit

June 19, 2020

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • The refraction status (presented as spherical equivalent, SE)

    Refractions were conducted with objective retinoscopy after cycloplegia, and performed by experienced optometrists.

    up to three years after surgery

Interventions

primary IOL implantationPROCEDURE

implant IOL in capsular bag after cataract extraction

Eligibility Criteria

Age7 Months - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

CC patients underwent surgery of cataratc extraction and primary intraocular lens (IOL) implantation at the Zhongshan Ophthalmic Center between 2010 and 2016 were recruited.

You may qualify if:

  • Children with uncomplicated surgeries
  • Children with unilateral/bilateral cataract

You may not qualify if:

  • Corneal diseases
  • Lens luxation
  • Glaucoma
  • Retinal diseases
  • Nystagmus and nanophthalmos

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Chen Weirong, MD

    SunYat-sen University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 22, 2020

Study Start

January 1, 2010

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

June 22, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

Locations

CN(1)