Pediatric CataractNCT03063216
Shanghai Pediatric Cataract Study
An observational study of Pediatric Cataract and Congenital Cataract, run by Evidence Based Cataract Study Group at 1 site in China.
Trial summary
The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of pediatric cataract participants, including congenital and traumatic cataract. Read more about this study
- Who is it for?
- Ages 2 months to 20 years
- Conditions the study is for
- Pediatric Cataract, Congenital Cataract, Traumatic Cataract
- What is being tested?
- intraocular lens implantation
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2009to 31 Dec 2045
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Medical centre: Eye and ENT Hospital of Fudan University
Who may be able to join
- Clinical diagnosis of pediatric cataract
- Must be able to cooperate with the ophthalmic examination
Who cannot join
- Clinical diagnosis of mental illness
- Mentally disabled
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye and ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Yi Lu, MD, (86)021-64377134, luyieent@163.com
Xiangjia Zhu, M.D.
About this study
Official title: Visual Outcome Evaluation and Genetic Analysis: Shanghai Pediatric Cataract Study
The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of pediatric cataract participants, including congenital and traumatic cataract. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of pediatric cataract.
- Conditions
- Pediatric Cataract, Congenital Cataract, Traumatic Cataract, Visual Outcome, Genetic Anticipation
- Being tested
- intraocular lens implantation
- Medical subject headings
- Anticipation, Genetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraocular lens implantationProcedure or surgery
1）Pediatric cataract patients with intraocular lens implantation and those without intraocular lens implantation；2）Traumatic cataract patients with intraocular lens implantation and those without intraocular lens implantation
| Study group | Role | What they receive |
|---|---|---|
| Congenital cataract group | Cataract patients diagnosed with congenital cataract. Receives: Procedure: intraocular lens implantation | |
| Traumatic cataract group | Cataract patients diagnosed with traumatic cataract. Receives: Procedure: intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the visual outcomes of pediatric cataract patients.
Visual outcomes are evaluated including visual acuity with or without correction, refractive changes, intraocular pressure, fundus function, fixation type, vision development, growth of axial length, contrast sensitivity and other visual outcome measurements.
Measured: Follow-up until ten years after surgery.
Genetic diversity based on biospecimen samples of pediatric cataract patients.
Sequencing of genes (including exons, promoters, 5' UTR and 3' UTR sequences) on a large scale to intensively investigate into the sites and functions of single nucleotide polymorphism (SNP) correlated with clinical features of congenital cataract patients, compared to traumatic cataract patients.Samples of blood, aqueous humor, anterior capsular membranes and lens tissues were applied for the genetic analysis.
Measured: Analyzed within six months after surgery.
Secondary outcomes (1)
Differences in the clinical phenotypes of pediatric cataract patients.
Cataract type and severity of ametropic cataract patients are evaluated and images are captured before receiving the cataract surgery.
Measured: Evaluated before receiving the cataract surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Jan 2009
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CataractStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Evidence Based Cataract Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Eye & ENT Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Yi Lu, M.D., Study chair, Eye & ENT Hospital of Fudan UniversityXiangjia Zhu, M.D., Study director, Eye & ENT Hospital of Fudan UniversityKeke Zhang, M.D., Principal investigator, Eye & ENT Hospital of Fudan UniversityWenwen He, M.D., Principal investigator, Eye & ENT Hospital of Fudan UniversityYu Du, M.D., Principal investigator, Eye & ENT Hospital of Fudan UniversityYinglei Zhang, M.D., Principal investigator, Eye & ENT Hospital of Fudan UniversityRuiqi Chang, M.D., Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063216
- Sponsor's protocol ID
- SH-PCS
- Status last verified
- Sep 2024
- First submitted
- 21 Feb 2017
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu X, He W, Du Y, Kraus CL, Xu Q, Sun T, Yu J, Lu Y. Presence of Posterior Staphyloma in Congenital Cataract Children. Curr Eye Res. 2019 Dec;44(12):1319-1324. doi: 10.1080/02713683.2019.1637437. Epub 2019 Jul 5.
PubMed 31246115
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcome Evaluation and Genetic Analysis: Shanghai Pediatric Cataract Study
- ClinicalTrials.gov ID
- NCT03063216
- Acronym / sponsor ID
- SH-PCS
- Conditions
- Pediatric Cataract, Congenital Cataract, Traumatic Cataract, Visual Outcome, Genetic Anticipation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Evidence Based Cataract Study GroupUniversity, hospital or other
- Collaborators
- Eye & ENT Hospital of Fudan University
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2045 (estimated)
- First posted
- 24 Feb 2017 (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 this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of pediatric cataract participants, including congenital and traumatic cataract. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of pediatric cataract.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital cataract group | – | Procedure: intraocular lens implantationCataract patients diagnosed with congenital cataract. |
| Traumatic cataract group | – | Procedure: intraocular lens implantationCataract patients diagnosed with traumatic cataract. |
Who may qualify
- Ages
- 2 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Medical centre: Eye and ENT Hospital of Fudan University
Key inclusion criteria (2 listed)
- Clinical diagnosis of pediatric cataract
- Must be able to cooperate with the ophthalmic examination
Key exclusion criteria (2 listed)
- Clinical diagnosis of mental illness
- Mentally disabled
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 |
|---|---|---|
| intraocular lens implantation1）Pediatric cataract patients with intraocular lens implantation and those without intraocular lens implantation；2）Traumatic cataract patients with intraocular lens implantation and those without intraocular lens implantation | Procedure or surgery | Congenital cataract group, Traumatic cataract group |
Primary outcome
Differences in the visual outcomes of pediatric cataract patients.
Time frame: Follow-up until ten years after surgery.
Visual outcomes are evaluated including visual acuity with or without correction, refractive changes, intraocular pressure, fundus function, fixation type, vision development, growth of axial length, contrast sensitivity and other visual outcome measurements.
Genetic diversity based on biospecimen samples of pediatric cataract patients.
Time frame: Analyzed within six months after surgery.
Sequencing of genes (including exons, promoters, 5' UTR and 3' UTR sequences) on a large scale to intensively investigate into the sites and functions of single nucleotide polymorphism (SNP) correlated with clinical features of congenital cataract patients, compared to traumatic cataract patients.Samples of blood, aqueous humor, anterior capsular membranes and lens tissues were applied for the genetic analysis.
1 secondary outcome
Differences in the clinical phenotypes of pediatric cataract patients.
Time frame: Evaluated before receiving the cataract surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 31246115Zhu X, He W, Du Y, Kraus CL, Xu Q, Sun T, Yu J, Lu Y. Presence of Posterior Staphyloma in Congenital Cataract Children. Curr Eye Res. 2019 Dec;44(12):1319-1324. doi: 10.1080/02713683.2019.1637437. Epub 2019 Jul 5.
- Individual participant dataSharing planned: Undecided
Related trials for Pediatric Cataract
Not yet recruiting
Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery
Pediatric Cataract, IOL Implantation
Not yet recruitingObservational study
The Effect of Vascular Imaging Devices on Success Rates of Peripheral Vascular Access in Pediatric Patients
Peripheral Vascular Access in Pediatric Patients, Peptic Ulcer
RecruitingObservational study
Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery
Congenital Cataract, Pediatric Cataract
RecruitingObservational study
The Cohort Study of Pediatric Cataract
Pediatric Cataract
Active, not recruitingObservational study
Glaucoma Following Pediatric Cataract Surgery
Glaucoma Following Pediatric Cataract Surgery, Glaucoma Secondary
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.
Yi Lu, M.D. study chair
Eye & ENT Hospital of Fudan University
Xiangjia Zhu, M.D. study director
Eye & ENT Hospital of Fudan University
Keke Zhang, M.D. principal investigator
Eye & ENT Hospital of Fudan 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 Pediatric Cataract and Congenital Cataract, run by Evidence Based Cataract Study Group 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 2 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: looking for participants now, as of the sponsor's last update on 27 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Lu, M.D. (+86-02164377134, luyieent@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the visual outcomes of pediatric cataract patients. (time frame: Follow-up until ten years after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03063216, which also lists 1 linked publication.
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 27 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.