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Clinical Trials/NCT02761850
NCT02761850
Completed
N/A

Developmental Profile of Ocular Refraction in Patients With Congenital Cataract: A Prospective Cohort Study

Sun Yat-sen University1 site in 1 country1,164 target enrollmentJanuary 2010
ConditionsCataract

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cataract
Sponsor
Sun Yat-sen University
Enrollment
1164
Locations
1
Primary Endpoint
The refraction status (presented as spherical equivalent, SE)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
January 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Haotian Lin

Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The refraction status (presented as spherical equivalent, SE)

Time Frame: Baseline

Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists.

Study Sites (1)

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