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Completed

NCT Number: NCT04441268

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

7 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

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 IOL implantation

Procedure

implant IOL in capsular bag after cataract extraction

Primary outcomes

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

    Time frame: up to three years after surgery

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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

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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