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

Sponsor

Tianjin Eye Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05948046

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myopia Convergence Insufficiency	Behavioral: Visual training in hospital

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Changes in EuroQol five dimensions questionnaire(EQ-5D-5L) score [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.
Changes in shortForm 6D(SF-6D) questionnaire score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 15 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Eye Hospital	Tianjin		China	300020

Sponsors and Collaborators

Tianjin Eye Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tianjin Eye Hospital

ClinicalTrials.gov Identifier:

NCT05948046

Other Study ID Numbers:

SGZX2203

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ocular Motility Disorders

Study Results

No Results Posted as of Jul 17, 2023