Developmental Profile of Ocular Refraction in Patients With Congenital Cataract

Completed

• Conditions: Cataract

• Registration Number: NCT02761850
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of prospective cohort study is to describe the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC.

Detailed Description

The refractive status is crucial to visual function and may change throughout life. For patients with congenital cataract (CC), the developmental profile of refraction is complicated due to the potential influences of diverse clinical manifestations and various treatments, and has not yet been fully characterized.

The investigator described the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC. The refraction data from CC patients provided in the study are of clinical significance to the guidelines for CC treatment, especially for IOL calculation concerning the laterality of CC.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1164

Inclusion Criteria

• Children with uncomplicated surgeries
• Children with unilateral/bilateral cataract

Exclusion Criteria

• Corneal diseases
• Lens luxation
• Glaucoma
• Retinal diseases
• Nystagmus and nanophthalmos

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The refraction status (presented as spherical equivalent, SE)	Baseline	Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China