Reduced ER-QOL in Families After Congenital Cataract Surgery

Prospective Cross-sectional Study Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824755
• Other study ID #: 2020080910
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: March 2021
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: January 1, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Prospective Cross-sectional Study

Intervention

Procedure:
• Yune Zhao
Yune Zhao did congenital cataract surgeries

Locations

Country	Name	City	State
China	Ophthalmology and Optometry Hospital	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Yune Zhao

Country where clinical trial is conducted

China, 

Outcome

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