- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04441268
Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Congenital Cataract
June 19, 2020 updated by: Haotian Lin, Sun Yat-sen University
Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Unilateral and Bilateral 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.
Study Overview
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 Type
Observational
Enrollment (Actual)
335
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Zhognshan Ophthalmic Center, Sun Yat-sen University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 12 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
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.
Description
Inclusion Criteria:
- Children with uncomplicated surgeries
- Children with unilateral/bilateral cataract
Exclusion Criteria:
- Corneal diseases
- Lens luxation
- Glaucoma
- Retinal diseases
- Nystagmus and nanophthalmos
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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up to three years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Chen Weirong, MD, SunYat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
December 30, 2019
Study Completion (Actual)
December 30, 2019
Study Registration Dates
First Submitted
June 19, 2020
First Submitted That Met QC Criteria
June 19, 2020
First Posted (Actual)
June 22, 2020
Study Record Updates
Last Update Posted (Actual)
June 22, 2020
Last Update Submitted That Met QC Criteria
June 19, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCPMOH2020-China-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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