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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04441268
Enrollment
335
Registered
2020-06-22
Start date
2010-01-01
Completion date
2019-12-30
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief 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.

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.

Interventions

implant IOL in capsular bag after cataract extraction

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Months to 12 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The refraction status (presented as spherical equivalent, SE)up to three years after surgeryRefractions were conducted with objective retinoscopy after cycloplegia, and performed by experienced optometrists.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026