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

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:
NCT01236755
First received: November 8, 2010
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Axial length [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    To determine the incidence of adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva


Estimated Enrollment: 90
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated 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.

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236755

Locations
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.
Investigators
Principal Investigator: Pauline Cho, PhD The Hong Kong Polytechnic University
  More Information

Publications:
Responsible Party: Pauline Cho, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01236755     History of Changes
Other Study ID Numbers: H-ZG50-2
Study First Received: November 8, 2010
Last Updated: July 10, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:
children
corneal reshaping
myopia
myopia progression
orthokeratology

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
Methamphetamine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014