Prospective Cross-sectional StudyNCT04824755
Reduced ER-QOL in Families After Congenital Cataract Surgery
A study testing Yune Zhao in people with Prospective Cross-sectional Study, run by Yune Zhao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Prospective Cross-sectional Study
- What is being tested?
- Yune Zhao
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Jan 2021
- 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 0 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- visually not significant cataract, and ophthalmic surgery (incisional or laser) within one month
Who cannot join
- parents who were inability to communicate were also excluded
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Prospective Cross-sectional Study
- Being tested
- Yune Zhao
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yune ZhaoProcedure or surgery
Yune Zhao did congenital cataract surgeries
| Study group | Role | What they receive |
|---|---|---|
| Demographics and clinic characteristics of children in different ages | Experimental | Not described Receives: Procedure: Yune Zhao |
| PedEyeQ domain scores | Experimental | Not described Receives: Procedure: Yune Zhao |
| Boxes represent first, median, and third quartile values. | Experimental | Not described Receives: Procedure: Yune Zhao |
| Parent of kids aged 0-4y and 5-11y PedEyeQ domain scores | Experimental | Not described Receives: Procedure: Yune Zhao |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender of Child
female,male
Measured: through study completion, an average of half a year
Parent/legal guardian Age
under 25,26-30,31-35,36-40,over 41
Measured: through study completion, an average of half a year
Parent/legal guardian completing questionnaires
father,mother,legal guardian
Measured: through study completion, an average of half a year
Native Place
city,not the city
Measured: 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
Measured: through study completion, an average of half a year
Staging operation
primary IOL implantation, aphakia, secondary IOL implantation;using questionnaire and telephone follow-up
Measured: 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
Measured: through study completion, an average of half a year
Amblyopia treatment
Cooperative,Average,Uncooperative,No treatment;using questionnaire and telephone follow-up
Measured: through study completion, an average of half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jul 2020
- Primary completion30 Nov 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prospective Cross-sectional StudyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
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
- NCT04824755
- Sponsor's protocol ID
- 2020080910
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04824755
- Acronym / sponsor ID
- 2020080910
- Conditions
- Prospective Cross-sectional Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Yune ZhaoUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 1 Apr 2021 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Demographics and clinic characteristics of children in different ages | Experimental | Procedure: Yune Zhao |
| PedEyeQ domain scores | Experimental | Procedure: Yune Zhao |
| Boxes represent first, median, and third quartile values. | Experimental | Procedure: Yune Zhao |
| Parent of kids aged 0-4y and 5-11y PedEyeQ domain scores | Experimental | Procedure: Yune Zhao |
Who may qualify
- Ages
- 0 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- visually not significant cataract, and ophthalmic surgery (incisional or laser) within one month
Key exclusion criteria (1 listed)
- parents who were inability to communicate were also excluded
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 |
|---|---|---|
| Yune ZhaoYune Zhao did congenital cataract surgeries | Procedure or surgery | Boxes represent first, median, and third quartile values., Demographics and clinic characteristics of children in different ages, Parent of kids aged 0-4y and 5-11y PedEyeQ domain scores, PedEyeQ domain scores |
Primary outcome
Gender of Child
Time frame: through study completion, an average of half a year
female,male
Parent/legal guardian Age
Time frame: through study completion, an average of half a year
under 25,26-30,31-35,36-40,over 41
Parent/legal guardian completing questionnaires
Time frame: through study completion, an average of half a year
father,mother,legal guardian
Native Place
Time frame: through study completion, an average of half a year
city,not the city
Parent/legal guardian highest level of education
Time frame: through study completion, an average of half a year
Primary school graduate,Junior-high graduate/technology secondary school graduate,high school graduate/junior college degree,College graduate,Postgraduate/professional degree
Staging operation
Time frame: through study completion, an average of half a year
primary IOL implantation, aphakia, secondary IOL implantation;using questionnaire and telephone follow-up
Postoperative timing
Time frame: through study completion, an average of half a year
Less than 1 year,1 to 2 years,2 to 3 years,More than 3 years;using questionnaire and telephone follow-up
Amblyopia treatment
Time frame: through study completion, an average of half a year
Cooperative,Average,Uncooperative,No treatment;using questionnaire and telephone follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yune Zhao in people with Prospective Cross-sectional Study, 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: finished, as of the sponsor's last update on 1 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gender of Child (time frame: through study completion, an average of half a year). The study lists 8 primary outcomes in all. 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 1 Apr 2021.