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OpenTrials
Completed

NCT Number: NCT04824755

Reduced ER-QOL in Families After Congenital Cataract Surgery

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.

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Key information

Conditions

Prospective Cross-sectional Study

Age range

0 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, 325027, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yune Zhao

Procedure

Yune Zhao did congenital cataract surgeries

Primary outcomes

  1. Gender of Child

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

    female,male

  2. 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

  3. Parent/legal guardian completing questionnaires

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

    father,mother,legal guardian

  4. Native Place

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

    city,not the city

  5. 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

  6. 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

  7. 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

  8. Amblyopia treatment

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

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

Sponsors and collaborators

Lead sponsor

Yune Zhao

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.