Peripheral Relative Refractive Power of Orthokeratology Lenses

Tianjin Eye Hospital53 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Myopia Myopia; Refractive Error

Interventions

orthokeratologyDEVICE

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

Sex: ALLMin age: 8 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Xiaoyan Yang

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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