Glaucoma After Congenital And Infantile Cataract Surgery

Glaucoma Clinical Trial

Official title:

Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04131114
• Other study ID #: CCPMOH2016-China-0303
• Status: Recruiting
• Start date: January 1, 2011
• Est. completion date: December 2021

Study information

• Verified date: April 2020
• Source: Sun Yat-sen University
• Contact: Haotian Lin, Ph.D
• Phone: +86-020-87333271
• Email: gddlht[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 241
• Est. completion date: December 2021
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract
• Glaucoma

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	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 suspected glaucoma/glaucoma after congenital cataracts	A Kaplan-Meier analysis was used.	3 years
Primary	Risk Factors of suspected glaucoma/glaucoma after congenital cataracts	Cox regression analysis was assessed	3 years