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Discontinuation of Lens Wear in New Ortho-k Children (DOEE2) (DOEE2)

This study has been completed.
Menicon Co., Ltd.
Information provided by (Responsible Party):
Pauline Cho, The Hong Kong Polytechnic University Identifier:
First received: November 8, 2010
Last updated: February 18, 2016
Last verified: February 2016
This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children.

Condition Intervention
Device: single-vision glasses
Device: ortho-k lenses

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (2) Discontinuation of Lens Wear in New Ortho-k Children

Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Axial length [ Time Frame: 14 months ]
    To determine and compare the rate of axial elongation in spectacle lens and contact lens wear periods

Secondary Outcome Measures:
  • Incidence of adverse effects [ Time Frame: 14 months ]
    To determine the incidence of adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva

Enrollment: 90
Study Start Date: October 2010
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: from single-vision glasses to ortho-k
Children will be required to wear single-vision glasses for the first 7 months of the study and will be switched to wear ortho-k lenses in the next 7 months
Device: single-vision glasses
Daily wear of glasses to correct vision
Other Name: CR-39 lenses
Device: ortho-k lenses
Nightly wear of lenses to correct vision in day time
Other Names:
  • orthokeratology
  • corneal reshaping therapy
  • Menicon Z Night lenses
  • Menicon Z Night Toric lenses

Detailed Description:

Children wearing ortho-k have been shown to have slower rate of myopic progression than those wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009). Younger myopic children (aged 6-10 years old) may have the faster increase in myopia than old myopic children (aged 11-15 years old), i.e. the rate of myopic progression may be different in different age groups and in children with different refractive status (Edwards 1999; Fan et al. 2004; Cheng et al. 2007). Although the refractive correction with ortho-k has been well documented, it is unknown whether the efficiency and reversibility of ortho-k for myopic reduction as well as myopic control are similar in children of different age and refractive groups.

In this 14-month study, the eyeball length in 45 younger (6-10 years old) and 45 older (11-15 years old) myopic children before and after ortho-k will be evaluated. Eyeball elongation will be determined for the first 7 months when single-vision glasses will be prescribed (Phase I) and the next 7 months when ortho-k will be prescribed (Phase I). Rate of myopic progression will be determined and compared between the two groups of children in the two phases.


Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age: between 6 to 15 years old
  • Myopia: between 1.50D and 4.50D in at least one eye
  • Spherical equivalent (SE): between -1.00D to -4.50D in both eyes
  • Astigmatism: ≤ 3.00D of axes 180 +/- 30 or ≤ 1.00D of other axes; and the amount is less than refractive sphere
  • 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 to wear contact lenses or spectacles on a daily basis
  • Can obtain good ortho-k results with the study lenses
  • Availability for follow-up for at least 14 months

Exclusion Criteria:

  • Strabismus at distance or near
  • Contraindication for contact lens wear and ortho-k (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)
  • Prior experience with the use of rigid lenses (including ortho-k)
  • Prior experience with myopia control treatment (e.g. refractive therapy or progressive spectacles)
  • Non-compliance to the follow up schedule
  • Non-compliance to the use of the prescribed optical correction
  • Poor ocular response to ortho-k lens wear
  • Significant residual refractive error after ortho-k treatment resulting in poor unaided vision (worse than 0.18 in logMAR scale)
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Please refer to this study by its identifier: NCT01236755

China, Hong Kong
School of Optometry, The Hong Kong Polytechnic University
Hong Kong, Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Menicon Co., Ltd.
Principal Investigator: Pauline Cho, PhD The Hong Kong Polytechnic University