NCT04342052

Brief Summary

To determine the incidence of glaucoma following bilateral congenital cataract removal and estimate the associated risk factors in a large cohort to provide guidance for clinical practice.

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
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 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

January 1, 2011

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

9.3 years

First QC Date

April 7, 2020

Last Update Submit

May 27, 2021

Conditions

GlaucomaCongenital Cataract

Outcome Measures

Primary Outcomes (1)

  • the incidence of glaucoma after congenital cataract surgery

    A Kaplan-Meier analysis was used

    baseline

Secondary Outcomes (1)

  • Risk factors of glaucoma after congenital cataract surgery

    baseline

Eligibility Criteria

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

A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital cataracts was performed.

You may qualify if:

  • a diagnosis of bilateral congenital cataracts, the etiologies include congenital idiopathic cataract and congenital cataract associated with a systemic syndrome or ocular anomalies;
  • cataract surgery performed in ZOC;
  • age at cataract removal younger than 16 years;

You may not qualify if:

  • the preoperative IOP was above 21 mm Hg;
  • family history of glaucoma;
  • signs of preoperative glaucoma were present, such as corneal clouding, corneal enlargement, excessive cup-disc ratio and myopic shift;
  • ocular trauma history;
  • previous surgery intervention and
  • they were noncompliant with our follow-up protocol to monitor the occurrence of glaucoma and glaucoma suspect.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • Wang J, Wu X, Wang Q, Zhou F, Chen H, Chen W, Lin D, Zhang X, Wang R, Chen J, Liu Z, Lin Z, Li X, Li J, Han Y, Liu Y, Lin H, Chen W. Incidence of and risk factors for suspected and definitive glaucoma after bilateral congenital cataract surgery: a 5-year follow-up. Br J Ophthalmol. 2024 Feb 21;108(3):476-483. doi: 10.1136/bjo-2022-322589.

    PMID: 36828619DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

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

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 10, 2020

Study Start

January 1, 2011

Primary Completion

April 8, 2020

Study Completion

December 31, 2024

Last Updated

June 1, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)