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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT04441268
Collaborator
(none)
335
Enrollment
1
Location
119.9
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: primary IOL implantation

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.

Study Design

Study Type:
Observational
Actual Enrollment :
335 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Unilateral and Bilateral Congenital Cataract
Actual Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Dec 30, 2019

Outcome Measures

Primary Outcome Measures

  1. The refraction status (presented as spherical equivalent, SE) [up to three years after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Months to 12 Years
Sexes Eligible for Study:
All
Inclusion Criteria:

  • Children with uncomplicated surgeries

  • Children with unilateral/bilateral cataract

Exclusion Criteria:

  • Corneal diseases

  • Lens luxation

  • Glaucoma

  • Retinal diseases

  • Nystagmus and nanophthalmos

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhognshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Study Chair: Chen Weirong, MD, SunYat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04441268
Other Study ID Numbers:
  • CCPMOH2020-China-2
First Posted:
Jun 22, 2020
Last Update Posted:
Jun 22, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract
Refractive Errors

Study Results

No Results Posted as of Jun 22, 2020