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Completed

NCT Number: NCT05305274

Age and Refraction in Predicting Myopia Progression in COVID-19

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.

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Key information

Conditions

Refraction Error Eye Diseases Myopia Refractive Errors

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Eye Hospital

Tianjin, 300020, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening

Other

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.

Primary outcomes

  1. changes of sphere

    Time frame: change from baseline at 36 months

    changes of sphere

  2. changes of cylinder

    Time frame: change from baseline at 36 months

    changes of cylinder

  3. changes of spherical equivalent

    Time frame: change from baseline at 36 months

    changes of spherical equivalent

  4. changes and distribution of visual acuity

    Time frame: change from baseline at 36 months

    changes and distribution of visual acuity

Sponsors and collaborators

Lead sponsor

Tianjin Eye Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2022
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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