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Completed

NCT Number: NCT02761850

Developmental Profile of Ocular Refraction in Patients With Congenital Cataract

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. The refraction status (presented as spherical equivalent, SE)

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Ministry of Health, China

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
May 4, 2016
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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