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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01236755
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : February 22, 2016
Menicon Co., Ltd.
Information provided by (Responsible Party):
Pauline Cho, The Hong Kong Polytechnic University

Brief Summary:
This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children.

Condition or disease Intervention/treatment Phase
Myopia Device: single-vision glasses Device: ortho-k lenses Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : October 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Incidence of adverse effects [ Time Frame: 14 months ]
    To determine the incidence of adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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