Reduced ER-QOL in Families After Congenital Cataract Surgery
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
1 other identifier
interventional
166
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedApril 1, 2021
March 1, 2021
5 months
March 1, 2021
March 30, 2021
Conditions
Outcome Measures
Primary Outcomes (8)
Gender of Child
female,male
through study completion, an average of half a year
Parent/legal guardian Age
under 25,26-30,31-35,36-40,over 41
through study completion, an average of half a year
Parent/legal guardian completing questionnaires
father,mother,legal guardian
through study completion, an average of half a year
Native Place
city,not the city
through study completion, an average of half a year
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
through study completion, an average of half a year
Staging operation
primary IOL implantation, aphakia, secondary IOL implantation;using questionnaire and telephone follow-up
through study completion, an average of half a year
Postoperative timing
Less than 1 year,1 to 2 years,2 to 3 years,More than 3 years;using questionnaire and telephone follow-up
through study completion, an average of half a year
Amblyopia treatment
Cooperative,Average,Uncooperative,No treatment;using questionnaire and telephone follow-up
through study completion, an average of half a year
Study Arms (4)
Demographics and clinic characteristics of children in different ages
EXPERIMENTALPedEyeQ domain scores
EXPERIMENTALBoxes represent first, median, and third quartile values.
EXPERIMENTALParent of kids aged 0-4y and 5-11y PedEyeQ domain scores
EXPERIMENTALInterventions
Yune Zhao did congenital cataract surgeries
Eligibility Criteria
You may qualify if:
- visually not significant cataract, and ophthalmic surgery (incisional or laser) within one month
You may not qualify if:
- parents who were inability to communicate were also excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yune Zhaolead
Study Sites (1)
Ophthalmology and Optometry Hospital
Wenzhou, Zhejiang, 325027, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
March 1, 2021
First Posted
April 1, 2021
Study Start
July 1, 2020
Primary Completion
November 30, 2020
Study Completion
January 1, 2021
Last Updated
April 1, 2021
Record last verified: 2021-03