Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Congenital Cataract

Cataract Clinical Trial

Official title:

Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Unilateral and Bilateral Congenital Cataract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441268
• Other study ID #: CCPMOH2020-China-2
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of prospective cohort study is to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract(CC) and to explore key factors associated with the rate of change.

Description:

Due to myopic shift, it's difficult to select power of IOL implanted in eye with congenital cataract. The developmental profile of refraction among patient with congenital catarat is has not yet been fully characterized. The investigator recruited a large cohort of Chinese CC children.After primary IOL implatation, routine examinations including retinoscopy were completed. Data were analysed to to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract and to explore key factors associated with the rate of change.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Gender: All
• Age group: 7 Months to 12 Years

Eligibility

Inclusion Criteria:

• Children with uncomplicated surgeries

• Children with unilateral/bilateral cataract

Exclusion Criteria:

• Corneal diseases

• Lens luxation

• Glaucoma

• Retinal diseases

• Nystagmus and nanophthalmos

Related Conditions & MeSH terms

• Cataract
• Refractive Errors

Intervention

Procedure:
• primary IOL implantation
implant IOL in capsular bag after cataract extraction

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	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 refraction status (presented as spherical equivalent, SE)	Refractions were conducted with objective retinoscopy after cycloplegia, and performed by experienced optometrists.	up to three years after surgery