Peripheral Relative Refractive Power of Orthokeratology Lenses

Effectiveness of Orthokeratology and Peripheral Retinal Refraction Changes

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.

Study Overview

• Status: Completed
• Conditions: Myopia; Myopia; Refractive Error
• Intervention / Treatment: Device: orthokeratology

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Xiaoyan Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children aged 8 to 15 years with myopia who are eligible for and fitted with orthokeratology lenses. Participants must demonstrate the ability to maintain adequate compliance with lens wear and follow-up requirements.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in axial length growth(ALG)	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.	Change from baseline in axial length at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Relative Peripheral Retinal Refraction	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.	Baseline (pre-lens wear), 1 month, 6 months, and 12 months after orthokeratology lens wear.

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): October 19, 2021

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Myopia; Refractive Errors
• Other Study ID Numbers: OK RPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No