Reduced ER-QOL in Families After Congenital Cataract Surgery

Not Applicable

Completed

• Conditions: Prospective Cross-sectional Study

• Registration Number: NCT04824755
• Lead Sponsor: Yune Zhao

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-11-30
• Study Completion: 2021-01-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-30
• Last Update Submitted: 2021-03-30
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Native Place	through study completion, an average of half a year	city,not the city
Postoperative timing	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
Parent/legal guardian completing questionnaires	through study completion, an average of half a year	father,mother,legal guardian
Gender of Child	through study completion, an average of half a year	female,male
Parent/legal guardian Age	through study completion, an average of half a year	under 25,26-30,31-35,36-40,over 41
Staging operation	through study completion, an average of half a year	primary IOL implantation, aphakia, secondary IOL implantation;using questionnaire and telephone follow-up
Parent/legal guardian highest level of education	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
Amblyopia treatment	through study completion, an average of half a year	Cooperative,Average,Uncooperative,No treatment;using questionnaire and telephone follow-up

Trial Locations

Locations (1)

Ophthalmology and Optometry Hospital; 🇨🇳 Wenzhou, Zhejiang, China