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Peripheral Optics in Myopia and Orthokeratology

Peripheral Refraction and Aberration in Myopic Progression and Myopic Control

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00978679
Enrollment
90
Registered
2009-09-17
Start date
2008-03-31
Completion date
2015-12-31
Last updated
2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Children, Peripheral refraction, Aberration, Eyeball length, Myopic control, Myopia, Corneal reshaping, Orthokeratology

Brief summary

The primary objective of the current study is to investigate changes in peripheral refraction and aberration in children wearing orthokeratology lenses and single-vision spectacles.

Detailed description

Apart from being effective in reducing low to moderate myopia, orthokeratology has been shown to have potential in retarding myopic progression. The central cornea is flattened and peripheral optics altered in orthokeratology and it has been suggested that orthokeratology slows myopic progression through the alteration of peripheral optics. The aim of the current study is to investigate the changes in peripheral refraction and aberration in children wearing orthokeratology (study group) and single-vision spectacles (control group).

Interventions

Nightly use of orthokeratology lenses to correct the refractive errors

DEVICESpectacles

Daily use of single vision lenses to correct refractive errors

Sponsors

Menicon Co., Ltd.
CollaboratorINDUSTRY
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

* Myopia (refractive sphere): \> 0.50D and ≤ 6.00D * Astigmatism: with-the-rule astigmatism (axes 180 +/- 30) ≤ 1.50D; astigmatism of other axes ≤ 0.50D * Spherical equivalent (SE): \> 0.50D and ≤ 6.75D (myopia) * Best corrected monocular visual acuity: equal to or better than 6/7.5 in Snellen scale * Willingness to wear contact lenses or spectacles on a daily basis * 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) * Prior experience with the use of rigid lenses (including orthokeratology) * Prior experience with myopic control treatment (e.g. refractive therapy or progressive spectacles) * 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)

Design outcomes

Primary

MeasureTime frame
Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026