Congenital CataractsNCT05527925
Effects of Visual Reconstruction on Brain Function and Structure in Children With Congenital Cataract
An observational study of Congenital Cataracts, run by Sun Yat-sen University at 1 site in China.
Trial summary
Children have considerable plasticity of the visual system during the formation and maturation of various visual functions at different ages. Congenital cataracts are the leading cause of treatable blindness in children. Read more about this study
- Who is it for?
- Ages 3 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Cataracts
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 1 Jun 2023
- 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 3 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with congenital cataracts
Who may be able to join
- Children with congenital cataracts
Who cannot join
- Other oculo-cerebral and systemic diseases that may affect the outcome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SunYat-senU
Guangzhou, Guangdong, 510000
Wei Xiao, 13535160850, 969834781@qq.com
About this study
Children have considerable plasticity of the visual system during the formation and maturation of various visual functions at different ages. Congenital cataracts are the leading cause of treatable blindness in children. With the continuous improvement of surgical approaches and surgical techniques, the success rate of congenital cataract surgery has been significantly improved clinically, and the visual function of children has been significantly improved after surgery. However, to date, there has been no experimental study of specific changes in the brain before and after surgery in children with congenital cataracts to explore its relationship with visual reconstruction. We aim to investigate the effects of congenital cataract surgery on the brain function and structure of children through preoperative and postoperative analysis and comparison of brain imaging such as BOLD-fMRI and DTI, and provide new ideas for the clinical treatment and prognostic assessment of this disease.
- Conditions
- Congenital Cataracts
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Brain testing of patients using MRI
| Study group | Role | What they receive |
|---|---|---|
| Congenital cataracts children (0~3 years) | Children with congenital cataracts between the ages of 0 and 3 years Receives: Device: MRI | |
| Normal children (0~3 years) | Children without congenital cataracts between the ages of 0 and 3 years Receives: Device: MRI | |
| Congenital cataracts children (6~18 years) | Children with congenital cataracts between the ages of 6 and 18 years Receives: Device: MRI | |
| Normal children (6~18 years) | Children without congenital cataracts between the ages of 6 and 18 years Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from functional magnetic resonance imaging
Measured: 1 week before surgery , 1 month, 3 month, 6 month after surgery
Secondary outcomes (1)
Change from best corrected visual acuity
Measured: 1 week before surgery , 1 month, 3 month, 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Apr 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CataractsStudies 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
- 100 participants (estimated)
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
- Haotian Lin, Study director, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527925
- Sponsor's protocol ID
- 2019KYPJ055
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Visual Reconstruction on Brain Function and Structure in Children With Congenital Cataract
- ClinicalTrials.gov ID
- NCT05527925
- Acronym / sponsor ID
- 2019KYPJ055
- Conditions
- Congenital Cataracts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 6 Sep 2022 (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.
Children have considerable plasticity of the visual system during the formation and maturation of various visual functions at different ages. Congenital cataracts are the leading cause of treatable blindness in children. With the continuous improvement of surgical approaches and surgical techniques, the success rate of congenital cataract surgery has been significantly improved clinically, and the visual function of children has been significantly improved after surgery. However, to date, there has been no experimental study of specific changes in the brain before and after surgery in children with congenital cataracts to explore its relationship with visual reconstruction. We aim to investigate the effects of congenital cataract surgery on the brain function and structure of children through preoperative and postoperative analysis and comparison of brain imaging such as BOLD-fMRI and DTI, and provide new ideas for the clinical treatment and prognostic assessment of this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Congenital cataracts children (0~3 years) | – | Device: MRIChildren with congenital cataracts between the ages of 0 and 3 years |
| Normal children (0~3 years) | – | Device: MRIChildren without congenital cataracts between the ages of 0 and 3 years |
| Congenital cataracts children (6~18 years) | – | Device: MRIChildren with congenital cataracts between the ages of 6 and 18 years |
| Normal children (6~18 years) | – | Device: MRIChildren without congenital cataracts between the ages of 6 and 18 years |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with congenital cataracts
Key inclusion criteria (1 listed)
- Children with congenital cataracts
Key exclusion criteria (1 listed)
- Other oculo-cerebral and systemic diseases that may affect the outcome
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 |
|---|---|---|
| MRIBrain testing of patients using MRI | Device | Congenital cataracts children (0~3 years), Congenital cataracts children (6~18 years), Normal children (0~3 years), Normal children (6~18 years) |
Primary outcome
Change from functional magnetic resonance imaging
Time frame: 1 week before surgery , 1 month, 3 month, 6 month after surgery
1 secondary outcome
Change from best corrected visual acuity
Time frame: 1 week before surgery , 1 month, 3 month, 6 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
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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.
Haotian Lin study director
Study Principal Investigator
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 Congenital Cataracts, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xiao (13535160850, 969834781@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from functional magnetic resonance imaging (time frame: 1 week before surgery , 1 month, 3 month, 6 month 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 6 Sep 2022.