Glaucoma After Congenital And Infantile Cataract Surgery
Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China
1 other identifier
observational
241
1 country
1
Brief Summary
Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard care. Therefore, this study investigated the incidence of and risk factors for suspected glaucoma/glaucoma in patients who have undergone surgery for congenital/infantile cataracts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
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, 2011
CompletedFirst Submitted
Initial submission to the registry
October 15, 2019
CompletedFirst Posted
Study publicly available on registry
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedApril 9, 2020
April 1, 2020
9 years
October 15, 2019
April 7, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
the incidence of suspected glaucoma/glaucoma after congenital cataracts
A Kaplan-Meier analysis was used.
3 years
Risk Factors of suspected glaucoma/glaucoma after congenital cataracts
Cox regression analysis was assessed
3 years
Eligibility Criteria
A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2016 was performed.
You may qualify if:
- a diagnosis of congenital/infantile cataracts without any surgical intervention;
- age younger than 10 years;
- cataract surgery performed at the Zhongshan Ophthalmic Center after enrollment
You may not qualify if:
- a preoperative IOP above 21 mm Hg;
- the presence of any preoperative sign of glaucoma, such as corneal enlargement, corneal clouding, excessive optic nerve cupping, or a family history of glaucoma;
- the presence of ocular trauma or other abnormalities, such as microcornea, microphthalmia, persistent hyperplastic primary vitreous, Peters anomaly, congenital aniridia, Marfan syndrome, lens dislocation, retinitis pigmentosa, high myopia, fundus lesions, rubella, and Lowe syndrome.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
October 15, 2019
First Posted
October 18, 2019
Study Start
January 1, 2011
Primary Completion
December 30, 2019
Study Completion
December 1, 2021
Last Updated
April 9, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share