Glaucoma After Congenital Cataract Surgery

Glaucoma Clinical Trial

Official title:

Glaucoma After Congenital Cataract Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04342052
• Other study ID #: CCPMOH2020
• Status: Enrolling by invitation
• Start date: January 1, 2011
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2025 was performed.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 351
• Est. completion date: December 31, 2024
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract
• Glaucoma

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of glaucoma after congenital cataract surgery	A Kaplan-Meier analysis was used	baseline
Secondary	Risk factors of glaucoma after congenital cataract surgery	Piecewise exponential survival models with mixed effects (PEWSMME) were used.(variables including demographic characters, surgery categories, clinical history, length of follow up).	baseline