Congenital CataractNCT03905044
Clinical Characteristics in Congenital Cataract Eyes
An observational study of Congenital Cataract, run by yin ying zhao.
Trial summary
This study involved children with congenial cataract eyes, who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). All medical records were reviewed for primary diagnosis. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- eyes with congenital cataracts
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Aug 2018
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with congenital cataracts
Who may be able to join
- children with congenital cataracts who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China)
Who cannot join
- ocular trauma
About this study
Official title: Clinical Characteristics of Three Pathological Types of Posterior Capsule Abnormality in Congenital Cataract Eyes
This study involved children with congenial cataract eyes, who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). All medical records were reviewed for primary diagnosis. All surgeries were performed by one experienced surgeon (Z.Y.E) and videos were collected for reviews in details. the clinical data after the surgery were also recorded for further analysis.
- Conditions
- Congenital Cataract
- Being tested
- eyes with congenital cataracts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eyes with congenital cataractsOther
observation
| Study group | Role | What they receive |
|---|---|---|
| CC | eyes with congenital cataracts Receives: Other: eyes with congenital cataracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication rate
the complication occurrent rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Jan 2011
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
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 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- yin ying zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yin ying zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905044
- Sponsor's protocol ID
- DXX-CC
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ding X, Xiang L, Wang Q, Wang D, Chang P, Li Z, Zhao Y, Chu F, Ma C, Zhao YE. Clinical Characteristics and Surgical Safety in Congenital Cataract Eyes with Three Pathological Types of Posterior Capsule Abnormalities. J Ophthalmol. 2020 Mar 16;2020:6958051. doi: 10.1155/2020/6958051. eCollection 2020.
PubMed 32280529
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Three Pathological Types of Posterior Capsule Abnormality in Congenital Cataract Eyes
- ClinicalTrials.gov ID
- NCT03905044
- Acronym / sponsor ID
- DXX-CC
- Conditions
- Congenital Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- yin ying zhaoUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 5 Apr 2019 (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.
This study involved children with congenial cataract eyes, who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). All medical records were reviewed for primary diagnosis. All surgeries were performed by one experienced surgeon (Z.Y.E) and videos were collected for reviews in details. the clinical data after the surgery were also recorded for further analysis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CC | – | Other: eyes with congenital cataractseyes with congenital cataracts |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with congenital cataracts
Key inclusion criteria (1 listed)
- children with congenital cataracts who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China)
Key exclusion criteria (1 listed)
- ocular trauma
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 |
|---|---|---|
| eyes with congenital cataractsobservation | Other | CC |
Primary outcome
complication rate
Time frame: 3 months
the complication occurrent rate
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 5 Apr 2019.
- Derived from this study: PubMed 32280529Ding X, Xiang L, Wang Q, Wang D, Chang P, Li Z, Zhao Y, Chu F, Ma C, Zhao YE. Clinical Characteristics and Surgical Safety in Congenital Cataract Eyes with Three Pathological Types of Posterior Capsule Abnormalities. J Ophthalmol. 2020 Mar 16;2020:6958051. doi: 10.1155/2020/6958051. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cataract, run by yin ying zhao.
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: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
complication rate (time frame: 3 months). 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 NCT03905044, 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 5 Apr 2019.