Congenital CataractNCT04824963
Analysis of Related Factors Affecting the Secondary Implantation of Intraocular Lens in Congenital Cataract
An observational study of Congenital Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
The ocular biometric parameters of the children with congenital cataract including preoperative pupil diameter, corneal diameter, axial length, anterior and posterior capsule size, iris adhesion. And then analysis whether the preoperative parameters were correlated with the implantation site of secondary implantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Cataract
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2021to 1 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Congenital cataract patient accepted secondary IOLs implantation at Eye hospital of Wenzhou Medical University.
Who may be able to join
- Patients were diagnosed as congenital cataract without lens after surgery
- Secondare IOLs implantation surgery was performed in Eye hospital of Wenzhou Medical University
Who cannot join
- Suffers from uveitis, glaucoma and other ocular diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027
Dandan Wang, MD, 18258227706, wangdan4827716@yahoo.com.cn
About this study
Official title: Analysis of Related Factors Affecting the Secondary Implantation of IOLs in Congenital Cataract
The ocular biometric parameters of the children with congenital cataract including preoperative pupil diameter, corneal diameter, axial length, anterior and posterior capsule size, iris adhesion. And then analysis whether the preoperative parameters were correlated with the implantation site of secondary implantation.
- Conditions
- Congenital Cataract
- Keywords
- secondary implantation, ciliary sulcus
What is being measured
The primary outcome is the main question the study is designed to answer.
pupil diameter
preoperative pupil diameter size
Measured: Before lens implantation
posterior capsule diameter
preoperative posterior capsule diameter size
Measured: Before lens implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start27 Mar 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
- Investigators
- Yune Zhao, Study director, Ophthalmology and Optometry Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824963
- Sponsor's protocol ID
- WDD-secondary implantation
- Status last verified
- Mar 2021
- First submitted
- 27 Mar 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Related Factors Affecting the Secondary Implantation of IOLs in Congenital Cataract
- ClinicalTrials.gov ID
- NCT04824963
- Acronym / sponsor ID
- WDD-secondary implantation
- Conditions
- Congenital Cataract
- Keywords
- secondary implantation, ciliary sulcus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 27 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 1 Apr 2021 (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 ocular biometric parameters of the children with congenital cataract including preoperative pupil diameter, corneal diameter, axial length, anterior and posterior capsule size, iris adhesion. And then analysis whether the preoperative parameters were correlated with the implantation site of secondary implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Congenital cataract patient accepted secondary IOLs implantation at Eye hospital of Wenzhou Medical University.
Key inclusion criteria (2 listed)
- Patients were diagnosed as congenital cataract without lens after surgery
- Secondare IOLs implantation surgery was performed in Eye hospital of Wenzhou Medical University
Key exclusion criteria (1 listed)
- Suffers from uveitis, glaucoma and other ocular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pupil diameter
Time frame: Before lens implantation
preoperative pupil diameter size
posterior capsule diameter
Time frame: Before lens implantation
preoperative posterior capsule diameter size
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
Related trials for Congenital Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Not yet recruiting
Partial Range Of Field IOLs in DMEK-Enabled Procedures
Cataract, Fuchs Endothelial Corneal Dystrophy
Recruiting
Guangke Lenses in Congenital Cataract
Congenital Cataract
Not yet recruitingObservational study
Postoperative CCT in FECD vs. Non-FECD
Fuchs Endothelial Corneal Dystrophy, Cataract (Post-operative Cataract Surgery Follow-up)
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.
Yune Zhao study director
Ophthalmology and Optometry Hospital
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 Cataract, run by Wenzhou Medical 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 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 23 Jun 2021. 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 Yune Zhao (+86 13819707056, zyehzeye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pupil diameter (time frame: Before lens implantation). 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?
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 23 Jun 2021.