Back to resultsReduced ER-QOL in Families After Congenital Cataract Surgery
Primary Purpose
Prospective Cross-sectional Study
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yune Zhao
Sponsored by
About this trial
This is an interventional prevention trial for Prospective Cross-sectional Study
Eligibility Criteria
Inclusion Criteria:
- visually not significant cataract, and ophthalmic surgery (incisional or laser) within one month
Exclusion Criteria:
- parents who were inability to communicate were also excluded
Sites / Locations
- Ophthalmology and Optometry Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Demographics and clinic characteristics of children in different ages
PedEyeQ domain scores
Boxes represent first, median, and third quartile values.
Parent of kids aged 0-4y and 5-11y PedEyeQ domain scores
Arm Description
Outcomes
Primary Outcome Measures
Gender of Child
female,male
Parent/legal guardian Age
under 25,26-30,31-35,36-40,over 41
Parent/legal guardian completing questionnaires
father,mother,legal guardian
Native Place
city,not the city
Parent/legal guardian highest level of education
Primary school graduate,Junior-high graduate/technology secondary school graduate,high school graduate/junior college degree,College graduate,Postgraduate/professional degree
Staging operation
primary IOL implantation, aphakia, secondary IOL implantation;using questionnaire and telephone follow-up
Postoperative timing
Less than 1 year,1 to 2 years,2 to 3 years,More than 3 years;using questionnaire and telephone follow-up
Amblyopia treatment
Cooperative,Average,Uncooperative,No treatment;using questionnaire and telephone follow-up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04824755
Brief Title
Reduced ER-QOL in Families After Congenital Cataract Surgery
Official Title
A Prospective Study on Assessments of the Eye-related Quality of Life, Functional Vision, and Their Determinants Using the PedEyeQ in Children After Congenital Cataract Surgery and Their Families
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)
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
Children after congenital cataract surgery experience a lower quality of life and reduced functional vision. Their families have also been seriously affected. Investigators should pay more attention to them, and measures should be administered to families.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prospective Cross-sectional Study
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Demographics and clinic characteristics of children in different ages
Arm Type
Experimental
Arm Title
PedEyeQ domain scores
Arm Type
Experimental
Arm Title
Boxes represent first, median, and third quartile values.
Arm Type
Experimental
Arm Title
Parent of kids aged 0-4y and 5-11y PedEyeQ domain scores
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Yune Zhao
Intervention Description
Yune Zhao did congenital cataract surgeries
Primary Outcome Measure Information:
Title
Gender of Child
Description
female,male
Time Frame
through study completion, an average of half a year
Title
Parent/legal guardian Age
Description
under 25,26-30,31-35,36-40,over 41
Time Frame
through study completion, an average of half a year
Title
Parent/legal guardian completing questionnaires
Description
father,mother,legal guardian
Time Frame
through study completion, an average of half a year
Title
Native Place
Description
city,not the city
Time Frame
through study completion, an average of half a year
Title
Parent/legal guardian highest level of education
Description
Primary school graduate,Junior-high graduate/technology secondary school graduate,high school graduate/junior college degree,College graduate,Postgraduate/professional degree
Time Frame
through study completion, an average of half a year
Title
Staging operation
Description
primary IOL implantation, aphakia, secondary IOL implantation;using questionnaire and telephone follow-up
Time Frame
through study completion, an average of half a year
Title
Postoperative timing
Description
Less than 1 year,1 to 2 years,2 to 3 years,More than 3 years;using questionnaire and telephone follow-up
Time Frame
through study completion, an average of half a year
Title
Amblyopia treatment
Description
Cooperative,Average,Uncooperative,No treatment;using questionnaire and telephone follow-up
Time Frame
through study completion, an average of half a year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
visually not significant cataract, and ophthalmic surgery (incisional or laser) within one month
Exclusion Criteria:
parents who were inability to communicate were also excluded
Facility Information:
Facility Name
Ophthalmology and Optometry Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
12. IPD Sharing Statement
Learn more about this trial
Reduced ER-QOL in Families After Congenital Cataract Surgery
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