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

Recruiting

• Conditions: Myopia; Convergence Insufficiency
• Interventions: Behavioral: Visual training in hospital

• Registration Number: NCT05948046
• Lead Sponsor: Tianjin Eye Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training group	Visual training in hospital	Patients with symptomatic convergence insufficiency who had received visual training

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China