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Completed

NCT Number: NCT00978692

Toric Orthokeratology - Slowing Eye Elongation

The aims of this study are to investigate the effects of ortho-k for astigmatic and myopic reduction and myopic control in children, and the long term effects on corneal curvatures and biomechanics.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry, The Hong KOng Polytechnic University

Hong Kong SAR, China

About this study

Ortho-k has been shown to be effective in correcting low myopia but relatively ineffective for astigmatism, using spherical reverse geometry lens designs. Toric ortho-k lenses have been introduced in recent years but the efficacy for astigmatic reduction and for myopic control in children have not been confirmed. The mechanism of myopic reduction in ortho-k cannot be fully explained by changes to the anterior corneal curvatures. It is therefore possible that other corneal parameters such as posterior corneal curvature and corneal biomechanics may contribute to the mechanism.

The current study aims at investigating the efficacy of toric ortho-k lenses for correcting myopic astigmatism and for retarding myopic progression in children compared to children wearing single-vision spectacles. Long term changes to other corneal parameters such as posterior cornea curvatures, topographical corneal thickness, corneal hysteresis, corneal resistance factor, with and without ortho-k lens wear will also be investigated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Myopia (refractive sphere): more than -0.50DS to -5.00DS
  • Astigmatism: with-the-rule astigmatism more than -1.25DC
  • Anisometropia: ≤ 1.50D in both refractive sphere
  • Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
  • 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 myopia 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

Toric Orthokeratology lenses

Device

Children wearing toric orthokeratology at night for correcting astigmatism and myopia will be the study group

Other names: corneal reshaping therapy

Single-Vision Spectacles

Device

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

Other names: glasses

Primary outcomes

  1. To determine the eyeball elongation in children wearing ortho-k lenses

    Time frame: Before lens wear, 6, 12,18, 24 months after lens wear

Secondary outcomes

  1. To determine the posterior corneal curvatures, topographic corneal thickness, corneal volume, corneal hysteresis and corneal resistance factor in a group of children and compare these parameters with the ortho-k children

    Time frame: Before lens wear, 6, 12,18, 24 months after lens wear

  2. To investigative the efficacy of toric orthokeratology for correcting astigmatism and myopia

    Time frame: Before lens wear, 6, 12,18, 24 months after lens wear

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Menicon Co., Ltd.

Registry information

Official study title

Toric Orthokeratology for Slowing Eye Elongation in Astigmatic Children

Acronym: TO-SEE

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 17, 2009
Registry last updated
Feb 22, 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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