Age and Refraction in Predicting Myopia Progression in COVID-19

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05305274
Collaborator
(none)
34,400
1
26
1322

Study Details

Study Description

Brief Summary

To determine the longitudinal changes of age and refraction in predicting myopia progression with risk under the coronavirus disease 2019 (COVID-19) pandemic in a 3-year follow-up of a Chinese cohort.

Condition or Disease Intervention/Treatment Phase
  • Other: screening

Detailed Description

This was part of the large-scale Tianjin Eye Study, a population-based cohort study that longitudinally investigates the relationship between the age, refraction, and development of childhood RE in Tianjin, China.

Study Design

Study Type:
Observational
Actual Enrollment :
34400 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Effect of Age and Refraction in Predicting Myopia Progression With Risk Under COVID-19 in a 3-year Follow-up of a Chinese Cohort
Actual Study Start Date :
Oct 1, 2019
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
2019 screening

34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.

Other: screening
This study included 34,400 students, as part of the Tianjin Eye Study who performed a 3-year follow-up from 2019 to 2021. All participants underwent yearly noncycloplegic refraction and ocular examinations. Time-related changes in sphere, cylinder, and spherical equivalent (SE) measurements in both sexes were analyzed.

2020 screening

34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.

Other: screening
This study included 34,400 students, as part of the Tianjin Eye Study who performed a 3-year follow-up from 2019 to 2021. All participants underwent yearly noncycloplegic refraction and ocular examinations. Time-related changes in sphere, cylinder, and spherical equivalent (SE) measurements in both sexes were analyzed.

2021 screening

34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.

Other: screening
This study included 34,400 students, as part of the Tianjin Eye Study who performed a 3-year follow-up from 2019 to 2021. All participants underwent yearly noncycloplegic refraction and ocular examinations. Time-related changes in sphere, cylinder, and spherical equivalent (SE) measurements in both sexes were analyzed.

Outcome Measures

Primary Outcome Measures

  1. changes of sphere [change from baseline at 36 months]

    changes of sphere

  2. changes of cylinder [change from baseline at 36 months]

    changes of cylinder

  3. changes of spherical equivalent [change from baseline at 36 months]

    changes of spherical equivalent

  4. changes and distribution of visual acuity [change from baseline at 36 months]

    changes and distribution of visual acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • no concurrent eye disease;

  • age 6-15 years.

Exclusion Criteria:
  • significant systemic illnesses

  • ocular conditions that could affect the corneal curvature, including congenital corneal diseases,

  • pterygium, keratoconus, other corneal degeneration or dystrophy conditions,

  • media opacity, uveitis, glaucoma

  • a history of intraocular surgery, refractive surgery,

  • neurologic or retinal diseases, current corneal refractive therapy (ortho-K),

  • low-dose atropine therapy for myopia control

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Eye Hospital Tianjin China 300020

Sponsors and Collaborators

  • Tianjin Eye Hospital

Investigators

  • Study Chair: Yan Wang, director, Tianjin Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tianjin Eye Hospital
ClinicalTrials.gov Identifier:
NCT05305274
Other Study ID Numbers:
  • 2022018
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022