Myopic Control for High Myopes Using Orthokeratology

The Hong Kong Polytechnic University52 enrolled

Overview

The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.

Orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic progression in low myopes. To date, clinical experience has shown the technique to be less effective in achieving full myopic reduction in high myopes. Would myopic control be possible for high myopes undergoing partial correction ortho-k treatment? A randomized, longitudinal study is designed to investigate the efficacy of partial correction ortho-k in retardation of myopic progression in high myopic children. Eye growth in terms of axial length elongation in children wearing ortho-k and over-spectacles (to correct residual refractive errors) (study group) and those wearing single-vision spectacles (control group) will be evaluated and compared.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myopia

Interventions

Orthokeratology lensesDEVICE

Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years

Single-vision spectacle lensesDEVICE

Daily use of spectacles to correct the refractive error for a period of two years

Eligibility

Sex: ALLMin age: 8 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Myopia (refractive sphere): \> 5.75D * Astigmatism: \< ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D * Spherical equivalent (SE): \> 5.75D * Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE * Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes * Willingness for randomization * Availability for follow-up for at least 2 years Exclusion Criteria: * Strabismus at distance or near * Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex * Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication) * Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)

Locations (1)

School of Optometry, The Hong Kong Polytechnic University

Hong Kong SAR, China

Outcomes

Primary Outcomes

Determine the change in cycloplegic axial length in the study and control groups

Time frame: 2 years

Secondary Outcomes

Determine the incidence of adverse effects in cornea, the palpebral, bulbar and tarsal conjunctiva in the study and the control groups

Time frame: 2 years

Rate of regression during the daytime

Time frame: 2 years

Data from ClinicalTrials.gov

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