Back to resultsCongenital Cataract With Persistent Fetal Vasculature
Primary Purpose
Persistent Fetal Vasculature, Congenital Cataract
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cataract surgery cataract extraction and intraocular implantation
Sponsored by
About this trial
This is an interventional screening trial for Persistent Fetal Vasculature focused on measuring persistent fetal vasculature, congenital cataract
Eligibility Criteria
Inclusion Criteria:
- congenital cataract with Persistent Fetal Vasculature
Exclusion Criteria:
- congenital cataract with no Persistent Fetal Vasculature
Sites / Locations
- Eye Hospital of Wenzhou Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cataract surgery cataract extraction and intraocular implanta
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03341624
Brief Title
Congenital Cataract With Persistent Fetal Vasculature
Official Title
Surgical Treatment and Prognosis of Congenital Cataract With Persistent Fetal Vasculature
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yune Zhao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Fetal Vasculature, Congenital Cataract
Keywords
persistent fetal vasculature, congenital cataract
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cataract surgery cataract extraction and intraocular implanta
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
cataract surgery cataract extraction and intraocular implantation
Primary Outcome Measure Information:
Title
visual acuity
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
congenital cataract with Persistent Fetal Vasculature
Exclusion Criteria:
congenital cataract with no Persistent Fetal Vasculature
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Man Hu, MD
Phone
+86-0571-88185666
Email
64344308@qq.com
Facility Information:
Facility Name
Eye Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Man Hu, MD
Phone
13738069080
Email
64344308@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Congenital Cataract With Persistent Fetal Vasculature
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