CataractNCT04441268
Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Congenital Cataract
An observational study of Cataract, run by Sun Yat-sen University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 7 months to 12 years
- Conditions the study is for
- Cataract
- What is being tested?
- primary IOL implantation
- Type of treatment
- Surgery or procedure
- How many people
- 335 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 months to 12 years
- All sexes
- Child
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.
Who may be able to join
- Children with uncomplicated surgeries
- Children with unilateral/bilateral cataract
Who cannot join
- Corneal diseases
- Lens luxation
- Glaucoma
- Retinal diseases
- Nystagmus and nanophthalmos
Trial locations and contacts
1 site in 1 country.
China1 site
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: 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.
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.
- Conditions
- Cataract
- Being tested
- primary IOL implantation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary IOL implantationProcedure or surgery
implant IOL in capsular bag after cataract extraction
What is being measured
The primary outcome is the main question the study is designed to answer.
The refraction status (presented as spherical equivalent, SE)
Refractions were conducted with objective retinoscopy after cycloplegia, and performed by experienced optometrists.
Measured: up to three years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jan 2010
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Chen Weirong, MD, Study chair, SunYat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441268
- Sponsor's protocol ID
- CCPMOH2020-China-2
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Unilateral and Bilateral Congenital Cataract
- ClinicalTrials.gov ID
- NCT04441268
- Acronym / sponsor ID
- CCPMOH2020-China-2
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 months to 12 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Children with uncomplicated surgeries
- Children with unilateral/bilateral cataract
Key exclusion criteria (5 listed)
- Corneal diseases
- Lens luxation
- Glaucoma
- Retinal diseases
- Nystagmus and nanophthalmos
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| primary IOL implantationimplant IOL in capsular bag after cataract extraction | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Weirong, MD study chair
SunYat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The refraction status (presented as spherical equivalent, SE) (time frame: up to three years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.