The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin

NCT ID: NCT05691296

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2024-12-31

Brief Summary

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The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.

Detailed Description

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The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.

Conditions

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Myopia High Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Home-school training group

There was a Letter Chart Accomodative Rock Training for accommodation facility at home and school everyday. This training usually lasted 2 minutes each time.

Group Type EXPERIMENTAL

Home training

Intervention Type BEHAVIORAL

Letter Chart Accomodative Rock Training for 2 minutes each time

School training

Intervention Type BEHAVIORAL

Letter Chart Accomodative Rock Training for 2 minutes each time

School training group

There was a Letter Chart Accomodative Rock Training for accommodation facility only at school everyday. This training usually lasted 2 minutes each time.

Group Type EXPERIMENTAL

School training

Intervention Type BEHAVIORAL

Letter Chart Accomodative Rock Training for 2 minutes each time

No training group

There was no such treatment for students.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home training

Letter Chart Accomodative Rock Training for 2 minutes each time

Intervention Type BEHAVIORAL

School training

Letter Chart Accomodative Rock Training for 2 minutes each time

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All students in grades 1 to 4
* Can cooperate with the examination of students

Exclusion Criteria

* Obvious strabismus and amblyopia
* Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
* History of ocular surgery
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tiajin Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

References

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Jonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, Logan NS, Liu M, Morgan I, Ohno-Matsui K, Parssinen O, Resnikoff S, Sankaridurg P, Saw SM, Smith EL 3rd, Tan DTH, Walline JJ, Wildsoet CF, Wu PC, Zhu X, Wolffsohn JS. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):6. doi: 10.1167/iovs.62.5.6.

Reference Type BACKGROUND
PMID: 33909032 (View on PubMed)

Other Identifiers

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Tianjin myopia Intervention

Identifier Type: -

Identifier Source: org_study_id

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