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

February 29, 2020 updated by: Pauline Cho, The Hong Kong Polytechnic University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • School of Optometry, The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ortho-k lenses
Children were switched to wear ortho-k lenses for 7 months after wearing single-vision glasses for 7 months
Device: single-vision glasses
Daily wear of glasses to correct vision in the first seven months of the study
Other Names:
  • CR-39 lenses
Device: ortho-k lenses
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Menicon Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (ESTIMATE)

November 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2020

Last Update Submitted That Met QC Criteria

February 29, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-ZG50-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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