The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency

July 13, 2023 updated by: Tianjin Eye Hospital
This trial is an observational cohort study. Patients aged 8-15 years with symptomatic convergence insufficiency and 150 patients with symptomatic convergence insufficiency who had not received visual training were selected from the Tianjin Eye Hospital Optometry Center and received 1 course of visual training treatment. Self-assessment and other assessments were combined, and the patient and guardian questionnaires were collected. The EQ-5D-Y and CHU9D scales were used to evaluate Chinese patients' health-related quality of life with symptomatic convergence insufficiency. The feasibility of the EQ-5D-Y and CHU9D scales in assessing the health-related quality of life of Chinese patients with symptomatic convergence insufficiency was analyzed. To assess the effectiveness of visual training on visual symptoms and improvement of quality of life in patients with symptomatic convergence insufficiency

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Contact

Study Locations

  • China
      • Tianjin, China, 300020
        • Recruiting
        • TianJin eye hospital
        • Contact:

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

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adolescent patients with insufficient astringency

Description

Inclusion Criteria:

  • 8~15 years old
  • Monocular best corrected visual acuity at distance and near was more than 0.8
  • Near exophoria 4Δ greater than distance exophoria
  • NPC ≥ 6cm
  • PFV ≤15△BO
  • Stereogram ≤500 ''
  • Score of CISS questionnaire ≥16 or COVD questionnaire≥20

Exclusion Criteria:

  • present constant strabismus, nystagmus or vertical phoria at distance or near.
  • developmental delay or ocular surgery
  • Myopia≤ -6.00D, Hyperopia ≥ +5.00D, Astigmatism ≥ 4.00D
  • Monocular Amplitude of accommodation<5D
  • Other diseases except myopia

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Training group
Patients with symptomatic convergence insufficiency who had received visual training
Behavioral: Visual training in hospital
Completion of 1 session of standardized visual training
Not training group
Patients with symptomatic convergence insufficiency who had not received visual training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in EuroQol five dimensions questionnaire(EQ-5D-5L) score
Time Frame: The changes between baseline and 3 months
The EQ-5D-5L questionnaires were used to evaluate the quality of life scores of myopic patients.The health utility value can be calculated by the number of the answer to the question. 0 means death and 1 means complete health.
The changes between baseline and 3 months
Changes in shortForm 6D(SF-6D) questionnaire score
Time Frame: The changes between baseline and 3 months
The SF-6D questionnaires were used to evaluate the quality of life scores of myopic patients.The health utility value can be calculated by the number of the answer to the question. 0 means death and 1 means complete health.
The changes between baseline and 3 months

Collaborators and Investigators

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

Sponsor

Tianjin Eye Hospital

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)

June 1, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGZX2203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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