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Glaucoma After Congenital Cataract Surgery

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ClinicalTrials.gov Identifier: NCT04342052
Recruitment Status : Enrolling by invitation
First Posted : April 10, 2020
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Study Description
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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.

Condition or disease
Glaucoma Congenital Cataract

Detailed Description:
A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2025 was performed.
Study Design
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Study Type : Observational
Estimated Enrollment : 351 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glaucoma After Congenital Cataract Surgery
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : April 8, 2020
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. the incidence of glaucoma after congenital cataract surgery [ Time Frame: baseline ]
    A Kaplan-Meier analysis was used


Secondary Outcome Measures :
  1. Risk factors of glaucoma after congenital cataract surgery [ Time Frame: baseline ]
    Piecewise exponential survival models with mixed effects (PEWSMME) were used.(variables including demographic characters, surgery categories, clinical history, length of follow up).


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital cataracts was performed.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342052


Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Sun Yat-sen University
More Information
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Responsible Party: Haotian Lin, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04342052    
Other Study ID Numbers: CCPMOH2020
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases