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OpenTrials
Completed

NCT Number: NCT00978679

Peripheral Optics in Myopia and Orthokeratology

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.

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Key information

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry, The Hong Kong Polytechnic University

Hong Kong, 000000, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

orthokeratology lenses

Device

Nightly use of orthokeratology lenses to correct the refractive errors

Other names: Menicon Z Night Lens 2, Menicon Z Night Lens 2 Toric

Spectacles

Device

Daily use of single vision lenses to correct refractive errors

Other names: Glasses, Eyeglasses

Primary outcomes

  1. Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Menicon Co., Ltd.

Registry information

Official study title

Peripheral Refraction and Aberration in Myopic Progression and Myopic Control

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2009
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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