Reduced ER-QOL in Families After Congenital Cataract Surgery

March 30, 2021 updated by: Yune Zhao

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Ophthalmology and Optometry Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Demographics and clinic characteristics of children in different ages
Procedure: Yune Zhao
Yune Zhao did congenital cataract surgeries
Experimental: PedEyeQ domain scores
Procedure: Yune Zhao
Yune Zhao did congenital cataract surgeries
Experimental: Boxes represent first, median, and third quartile values.
Procedure: Yune Zhao
Yune Zhao did congenital cataract surgeries
Experimental: Parent of kids aged 0-4y and 5-11y PedEyeQ domain scores
Procedure: Yune Zhao
Yune Zhao did congenital cataract surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender of Child
Time Frame: through study completion, an average of half a year
female,male
through study completion, an average of half a year
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
through study completion, an average of half a year
Parent/legal guardian completing questionnaires
Time Frame: through study completion, an average of half a year
father,mother,legal guardian
through study completion, an average of half a year
Native Place
Time Frame: through study completion, an average of half a year
city,not the city
through study completion, an average of half a year
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
through study completion, an average of half a year
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
through study completion, an average of half a year
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
through study completion, an average of half a year
Amblyopia treatment
Time Frame: through study completion, an average of half a year
Cooperative,Average,Uncooperative,No treatment;using questionnaire and telephone follow-up
through study completion, an average of half a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yune Zhao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020080910

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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