MyopiaNCT05948046
The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency
An observational study of Myopia and Convergence Insufficiency, run by Tianjin Eye Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Myopia, Convergence Insufficiency
- What is being tested?
- Visual training in hospital
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Child
Study population: Adolescent patients with insufficient astringency
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, 300020
Yue Zhang, MD, +862227306525, zhangyue_1225@126.com
About this study
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
- Being tested
- Visual training in hospital
- Medical subject headings
- Myopia, Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual training in hospitalBehavioural
Completion of 1 session of standardized visual training
| Study group | Role | What they receive |
|---|---|---|
| Training group | Patients with symptomatic convergence insufficiency who had received visual training Receives: Behavioral: Visual training in hospital | |
| Not training group | Patients with symptomatic convergence insufficiency who had not received visual training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The changes between baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Jun 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948046
- Sponsor's protocol ID
- SGZX2203
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency
- ClinicalTrials.gov ID
- NCT05948046
- Acronym / sponsor ID
- SGZX2203
- Conditions
- Myopia, Convergence Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | – | Behavioral: Visual training in hospitalPatients with symptomatic convergence insufficiency who had received visual training |
| Not training group | – | –Patients with symptomatic convergence insufficiency who had not received visual training |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Adolescent patients with insufficient astringency
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual training in hospitalCompletion of 1 session of standardized visual training | Behavioural | Training group |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Convergence Insufficiency, run by Tianjin Eye Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Zhang, MD (+862227306525, zhangyue_1225@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in EuroQol five dimensions questionnaire(EQ-5D-5L) score (time frame: The changes between baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.