NCT03341624

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 9, 2017

Last Update Submit

November 9, 2017

Conditions

Persistent Fetal VasculatureCongenital Cataract

Keywords

persistent fetal vasculaturecongenital cataract

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Study Arms (1)

cataract surgery cataract extraction and intraocular implanta

EXPERIMENTAL
Procedure: cataract surgery cataract extraction and intraocular implantation

Interventions

cataract surgery cataract extraction and intraocular implantationPROCEDURE
cataract surgery cataract extraction and intraocular implanta

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • congenital cataract with Persistent Fetal Vasculature

You may not qualify if:

  • congenital cataract with no Persistent Fetal Vasculature

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

RECRUITING

MeSH Terms

Conditions

Persistent Hyperplastic Primary Vitreous

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Man Hu, MD

CONTACT

+86-0571-8818566664344308@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 14, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)