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Completed

NCT Number: NCT01236755

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

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

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry, The Hong Kong Polytechnic University

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

single-vision glasses

Device

Daily wear of glasses to correct vision in the first seven months of the study

Other names: CR-39 lenses

ortho-k lenses

Device

Nightly wear of lenses to correct vision in day time in the second seven months of the study

Other names: orthokeratology, corneal reshaping therapy, Menicon Z Night lenses, Menicon Z Night Toric lenses

Primary outcomes

  1. Change in Axial Elongation in the Two Study Phases

    Time frame: 14 months

    Axial elongation in children during the two study phases. Phase I: 7 months wearing single-vision spectacles. Phase II: 7 months wearing orthokeratology

Secondary outcomes

  1. Number of Participants With Serious Adverse Effects

    Time frame: 14 months

    Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Menicon Co., Ltd.

Registry information

Official study title

Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (2) Discontinuation of Lens Wear in New Ortho-k Children

Acronym: DOEE2

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 9, 2010
Registry last updated
Mar 11, 2020

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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