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OpenTrials
Completed

NCT Number: NCT07294404

Peripheral Relative Refractive Power of Orthokeratology Lenses

Orthokeratology (OK) has been demonstrated to be an effective intervention for slowing axial elongation in children with myopia. The proposed mechanism of action is the induction of peripheral myopic defocus, which reduces relative peripheral hyperopia on the retina.

This study aims to evaluate changes in relative peripheral retinal refraction before and after OK lens wear using wide-field multispectral retinal refractive topography. The study will also investigate the relationship between these retinal refractive changes and the effectiveness of OK in controlling axial elongation.

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Key information

Conditions

Myopia Eye Diseases Myopia; Refractive Error Refractive Errors

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiaoyan Yang

Tianjin, Tianjin Municipality, 300020, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 8 to 15 years old
  • myopia of -4.00D or lower,
  • regular astigmatism ≤1.50D and non-regular astigmatism ≤1.00D
  • intraocular pressure ≤21mmHg
  • understand the purpose of the study and have good hygiene and regular follow-up

Exclusion criteria

  • unilateral
  • immunocompromised subjects with systemic diseases (such as acute or chronic sinusitis, diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric patients, etc.)
  • complicated with other eye diseases that affect OK lens wearing, such as dacryocystitis, blepharitis and other inflammation, glaucoma, etc.
  • BCVA less than 1.0
  • children with corneal curvature less than 40.00D or higher than 46.00D.

Treatment and study plan

Orthokeratology

Device

All participants will be fitted with orthokeratology lenses of the same design. The primary objective is to assess changes in relative peripheral retinal refraction before and after lens wear.

Primary outcomes

  1. Changes in axial length growth(ALG)

    Time frame: Change from baseline in axial length at 12 months

    Axial length will be measured using an ocular biometer (AL-Scan, NIDEK, Japan). Axial length growth (ALG) will be defined as the difference between the 1-year measurement and baseline.

Secondary outcomes

  1. Change in Relative Peripheral Retinal Refraction

    Time frame: Baseline (pre-lens wear), 1 month, 6 months, and 12 months after orthokeratology lens wear.

    Retinal refractive power will be measured using multispectral retinal refractive topography. Relative peripheral retinal refraction will be calculated as the difference between peripheral and central retinal refractive power. Changes from pre- to post-orthokeratology lens wear will be evaluated.

Sponsors and collaborators

Lead sponsor

Tianjin Eye Hospital

Other

Registry information

Official study title

Effectiveness of Orthokeratology and Peripheral Retinal Refraction Changes

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2025
Registry last updated
Mar 2, 2026

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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