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CompletedNCT04824755Updated Apr 1, 2021

Reduced ER-QOL in Families After Congenital Cataract Surgery

An interventional study of Yune Zhao in Prospective Cross-sectional Study, sponsored by Yune Zhao. Completed at 1 site in China. Open to participants aged 0 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by Yune Zhao · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2020, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
0 Years to 11 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Prospective Cross-sectional Study
03

In context

Lead sponsor

Yune Zhao is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • visually not significant cataract, and ophthalmic surgery (incisional or laser) within one month

Exclusion criteria

Exclusion Criteria:

  • parents who were inability to communicate were also excluded
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
166 participants (actual)

Study arms

  • Experimental
    Demographics and clinic characteristics of children in different ages

    Procedure: Yune Zhao

  • Experimental
    PedEyeQ domain scores

    Procedure: Yune Zhao

  • Experimental
    Boxes represent first, median, and third quartile values.

    Procedure: Yune Zhao

  • Experimental
    Parent of kids aged 0-4y and 5-11y PedEyeQ domain scores

    Procedure: Yune Zhao

Interventions

  • ProcedureYune Zhao

    Yune Zhao did congenital cataract surgeries

06

What researchers measure

Primary outcomes

  1. Gender of Child

    female,male

    Time frame: through study completion, an average of half a year

  2. Parent/legal guardian Age

    under 25,26-30,31-35,36-40,over 41

    Time frame: through study completion, an average of half a year

  3. Parent/legal guardian completing questionnaires

    father,mother,legal guardian

    Time frame: through study completion, an average of half a year

  4. Native Place

    city,not the city

    Time frame: through study completion, an average of half a year

  5. 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

    Time frame: through study completion, an average of half a year

  6. Staging operation

    primary IOL implantation, aphakia, secondary IOL implantation;using questionnaire and telephone follow-up

    Time frame: through study completion, an average of half a year

  7. Postoperative timing

    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

  8. Amblyopia treatment

    Cooperative,Average,Uncooperative,No treatment;using questionnaire and telephone follow-up

    Time frame: through study completion, an average of half a year

07

Study locations

1 site
  • Ophthalmology and Optometry Hospital
    Wenzhou, Zhejiang 325027, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04824755
Lead sponsor
Yune Zhao
Responsible party
Yune Zhao (Director, Wenzhou Medical University) — Sponsor-investigator
First posted
Apr 1, 2021
Start date
Jul 1, 2020
Primary completion
Nov 30, 2020
Completion
Jan 1, 2021
Last update
Apr 1, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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