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

NCT05948046 | Unknown DMC

• 1 other identifier: SGZX2203
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Myopia; Convergence Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Training group

Patients with symptomatic convergence insufficiency who had received visual training

Behavioral: Visual training in hospital

Not training group

Patients with symptomatic convergence insufficiency who had not received visual training

Interventions

Visual training in hospital BEHAVIORAL

Completion of 1 session of standardized visual training

Training group

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent patients with insufficient astringency

You may qualify if:

• \~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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, 300020, China

RECRUITING

MeSH Terms

Conditions

Myopia; Ocular Motility Disorders

Interventions

Hospitals

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Central Study Contacts

Yue Zhang, MD

CONTACT

+862227306525; zhangyue_1225@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 17, 2023
• Study Start: June 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: June 30, 2024
• Last Updated: July 17, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)