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CompletedNCT04441268Updated Jun 22, 2020

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

An observational study in Cataract, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 7 Months to 12 Years. Per ClinicalTrials.gov, last updated 2020-06-22.

Sponsored by Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
335
Ages
7 Months to 12 Years
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Cataract
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In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 335 is above the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Months to 12 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

CC patients underwent surgery of cataratc extraction and primary intraocular lens (IOL) implantation at the Zhongshan Ophthalmic Center between 2010 and 2016 were recruited.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
335 participants (actual)
Patient registry
No

Interventions

  • Procedureprimary IOL implantation

    implant IOL in capsular bag after cataract extraction

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What researchers measure

Primary outcomes

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

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

    Time frame: up to three years after surgery

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Study locations

1 site
  • Zhognshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04441268
Lead sponsor
Sun Yat-sen University
Responsible party
Haotian Lin (Clinical Professor, Sun Yat-sen University) — Principal investigator
First posted
Jun 22, 2020
Start date
Jan 1, 2010
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019
Last update
Jun 22, 2020

Study contacts

Chen Weirong, MD
study chair · SunYat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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