NCT03640780

Brief Summary

In the current study, the investigators analyzed the surgical RWD of 2,421 children with childhood cataracts from the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH) at the Zhognshan Ophthalmic Center and proposed data-based clinical experience for the timings of cataract extraction and IOL implantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,421

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

9.9 years

First QC Date

August 18, 2018

Last Update Submit

August 23, 2018

Conditions

Childhood Cataract

Keywords

surgical timingcataract extractionIOL implantationchildhood cataractreal-world data

Outcome Measures

Primary Outcomes (1)

  • Surgical age

    the surgical ages of two groups

    2005-2014

Study Arms (2)

cataract extraction (CE)

Patients received CE without IOL implantation in the first surgical stage, and received IOL implantation at secondary surgical stage.

Other: observation

cataract extraction and IOL implantation

Patients received CE and IOL implantation in the first surgical stage.

Other: observation

Interventions

observationOTHER

The surgical ages and other information between two groups were compared.

cataract extraction (CE)cataract extraction and IOL implantation

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

hospital-based

You may qualify if:

  • childhood cataracts present at the ZOC at the first time age: 0-18 years

You may not qualify if:

  • complicated with other type of cataracts

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

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 18, 2018

First Posted

August 21, 2018

Study Start

January 1, 2005

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

CN(1)