Peripheral Relative Refractive Power of Orthokeratology Lenses

NCT07294404 | Completed

• 1 other identifier: OK RPR
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia; Refractive Error; Myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Relative Peripheral Retinal Refraction

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

Interventions

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.

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Xiaoyan Yang

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: January 10, 2020
• Primary Completion: June 15, 2021
• Study Completion: October 19, 2021
• Last Updated: March 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)