Persistent Fetal VasculatureNCT03341624
Congenital Cataract With Persistent Fetal Vasculature
A study testing cataract surgery cataract extraction and intraocular implantation in people with Persistent Fetal Vasculature and Congenital Cataract, run by Yune Zhao at 1 site in China.
Trial summary
To observe the clinical characteristics and surgical treatment of 24 cases of congenital cataract complicated with Persistent Fetal Vasculature (PFV) in 28 cases of congenital cataract in our hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Persistent Fetal Vasculature, Congenital Cataract
- What is being tested?
- cataract surgery cataract extraction and intraocular implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- congenital cataract with Persistent Fetal Vasculature
Who cannot join
- congenital cataract with no Persistent Fetal Vasculature
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027
Man Hu, MD, 13738069080, 64344308@qq.com
About this study
Official title: Surgical Treatment and Prognosis of Congenital Cataract With Persistent Fetal Vasculature
To observe the clinical characteristics and surgical treatment of 24 cases of congenital cataract complicated with Persistent Fetal Vasculature (PFV) in 28 cases of congenital cataract in our hospital.
Read the detailed description
methods the clinical data of 28 eyes of 24 children with congenital cataract complicated with PFV who underwent surgical treatment in our hospital were analyzed retrospectively.
- Conditions
- Persistent Fetal Vasculature, Congenital Cataract
- Being tested
- cataract surgery cataract extraction and intraocular implantation
- Keywords
- persistent fetal vasculature, congenital cataract
- Medical subject headings
- Persistent Hyperplastic Primary Vitreous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgery cataract extraction and intraocular implantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| cataract surgery cataract extraction and intraocular implanta | Experimental | Not described Receives: Procedure: cataract surgery cataract extraction and intraocular implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
level1：visual acuity≥0.3；level 2：0.1≤visual acuity<0.3；level 3：0.02 ≤visual acuity<0.1；level 4：≤0.02
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Fetal VasculatureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yune Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341624
- Sponsor's protocol ID
- HM-PFV-001
- Status last verified
- Nov 2017
- First submitted
- 9 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment and Prognosis of Congenital Cataract With Persistent Fetal Vasculature
- ClinicalTrials.gov ID
- NCT03341624
- Acronym / sponsor ID
- HM-PFV-001
- Conditions
- Persistent Fetal Vasculature, Congenital Cataract
- Keywords
- persistent fetal vasculature, congenital cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yune ZhaoUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 Nov 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.
To observe the clinical characteristics and surgical treatment of 24 cases of congenital cataract complicated with Persistent Fetal Vasculature (PFV) in 28 cases of congenital cataract in our hospital.
Detailed description
methods the clinical data of 28 eyes of 24 children with congenital cataract complicated with PFV who underwent surgical treatment in our hospital were analyzed retrospectively.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cataract surgery cataract extraction and intraocular implanta | Experimental | Procedure: cataract surgery cataract extraction and intraocular implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- congenital cataract with Persistent Fetal Vasculature
Key exclusion criteria (1 listed)
- congenital cataract with no Persistent Fetal Vasculature
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 |
|---|---|---|
| cataract surgery cataract extraction and intraocular implantation | Procedure or surgery | cataract surgery cataract extraction and intraocular implanta |
Primary outcome
visual acuity
Time frame: 2 years
level1：visual acuity≥0.3；level 2：0.1≤visual acuity<0.3；level 3：0.02 ≤visual acuity<0.1；level 4：≤0.02
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery cataract extraction and intraocular implantation in people with Persistent Fetal Vasculature and Congenital Cataract, run by Yune Zhao 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 14 Nov 2017. 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 Man Hu, MD (+86-0571-88185666, 64344308@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: 2 years). 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 14 Nov 2017.