Myopic Control for High Myopes Using Orthokeratology (HM-PRO)

The Hong Kong Polytechnic University

Status: Completed

Conditions: Myopia

Treatments: Device: Single-vision spectacle lenses; Device: Orthokeratology lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT00977236

4-RP3M

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 8 to 11 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Orthokeratology lenses

Experimental group

Description:

Children wearing orthokeratology at night for partial correction and spectacles at daytime for residual refractive error will be study group

Treatment:

Device: Orthokeratology lenses

Single-vision spectacle lenses

Other group

Description:

Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group

Treatment:

Device: Single-vision spectacle lenses