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Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children (DOEE1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Menicon Co., Ltd.
Information provided by (Responsible Party):
Pauline Cho, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01236742
First received: November 8, 2010
Last updated: July 10, 2013
Last verified: July 2013

November 8, 2010
July 10, 2013
July 2010
January 2013   (final data collection date for primary outcome measure)
Axial length [ Time Frame: 14 months ] [ Designated as safety issue: No ]
To determine the change in axial length in the study and control groups
Same as current
Complete list of historical versions of study NCT01236742 on ClinicalTrials.gov Archive Site
Incidence of adverse effects [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
To determine the incidence of adverse effects on the cornea, the palpebral, bulbar and tarsal conjunctiva in the study and the control groups
Same as current
Not Provided
Not Provided
 
Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children
Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (1) Discontinuation of Lens Wear in Existing Ortho-k Children

The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects who stop the treatment with subjects who continue ortho-k lens wear and control subjects wearing single-vision glasses.

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). Both studies showed that the effect of myopic control was most significant during the first six months of the treatment. It is unknown whether the myopic control effect would dissipate upon the discontinuation of the treatment or whether the myopic control effect only happened in the first six month of lens wear and was maintained thereafter. The current study aims at evaluating the effect of discontinuation of ortho-k treatment on myopic control in children who are currently on the treatment. This knowledge is necessary and important as patients/parents have concerns about the permanent dependency on ortho-k once they enrolled in the treatment.

Children who have been on the treatment for two years and have recently completed the myopic control studies at The Hong Kong Polytechnic University, i.e. the ROMIO, TO-SEE and HM-PRO studies, will be invited to participate in this 14-month study. Ortho-k subjects will be randomly assigned to study group or the ortho-k control group. The study group subjects will be required to stop lens wear for 7 months at the completion of the previous study (Phase I) and resume lens wear for next 7 months (Phase II). The ortho-k control group subjects will be required to continue the current treatment for another 14 months. Control subjects in the existing myopic control studies will be required to continue using the same treatment, i.e. single-vision glasses, for another 14 months. Rate of myopic progression among the 3 groups and at the two study phases will be determined and compared.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Myopia
  • Device: ortho-k lenses
    nightly wear of orthokeratology lenses to correct vision
    Other Names:
    • orthokeratology
    • corneal reshaping therapy
    • Menicon Z Night lenses
    • Menicon Z Night Toric lenses
  • Device: single-vision glasses
    daily wear of spectacle glasses to correct vision
    Other Name: CR-39 lenses
  • Experimental: single-vision glasses and ortho-k lenses
    Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months
    Interventions:
    • Device: ortho-k lenses
    • Device: single-vision glasses
  • Active Comparator: ortho-k lenses
    Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group
    Intervention: Device: ortho-k lenses
  • single-vision glasses
    Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group
    Intervention: Device: single-vision glasses

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
August 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 8-14 years old (inclusive)
  • Subjects who have completed the ROMIO, TO-SEE or HM-PRO studies at The Hong Kong Polytechnic University
  • Willingness to be randomized into groups (for ortho-k subjects)
  • Availability for follow-up for at least 14 months

Exclusion Criteria:

  • Non-compliance to the follow up schedule
  • Non-compliance to the assigned optical correction (i.e. single-vision glasses or ortho-k lenses)
  • 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)
Both
8 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01236742
H-ZG50-1
No
Pauline Cho, The Hong Kong Polytechnic University
The Hong Kong Polytechnic University
Menicon Co., Ltd.
Principal Investigator: Pauline Cho, PhD The Hong Kong Polytechnic University
The Hong Kong Polytechnic University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP