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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05948046
• Other study ID #: SGZX2203
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Tianjin Eye Hospital
• Contact: Yue Zhang, MD
• Phone: +862227306525
• Email: zhangyue_1225[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: April 1, 2024
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

Inclusion Criteria:

• 8~15 years old
• Monocular best corrected visual acuity at distance and near was more than 0.8
• Near exophoria 4? 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

Related Conditions & MeSH terms

• Convergence Insufficiency
• Myopia
• Ocular Motility Disorders

Intervention

Behavioral:
• Visual training in hospital
Completion of 1 session of standardized visual training

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in EuroQol five dimensions questionnaire(EQ-5D-5L) score	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
Primary	Changes in shortForm 6D(SF-6D) questionnaire score	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