Glaucoma After Congenital And Infantile Cataract Surgery

• Conditions: Congenital Cataract; Glaucoma

• Registration Number: NCT04131114
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2021 was performed.

Study Timeline

• Study Start: 2011-01-01
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-18
• Primary Completion: 2019-12-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the incidence of suspected glaucoma/glaucoma after congenital cataracts	3 years	A Kaplan-Meier analysis was used.
Risk Factors of suspected glaucoma/glaucoma after congenital cataracts	3 years	Cox regression analysis was assessed

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China