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

November 9, 2017 updated by: Pauline Cho, The Hong Kong Polytechnic University

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.

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). 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.

Study Type

Interventional

Enrollment (Actual)

53

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

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • CR-39 lenses
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
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
Other: 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
Device: single-vision glasses
daily wear of spectacle glasses to correct vision
Other Names:
  • CR-39 lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Axial Length
Time Frame: Baseline, 7 months, and 14 months after baseline
To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects
Baseline, 7 months, and 14 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Effects
Time Frame: 14 months
The observation of serious and non-serious adverse events in the 14 months of study period
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

July 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 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)

December 18, 2017

Last Update Submitted That Met QC Criteria

November 9, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-ZG50-1

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.

Clinical Trials on Myopia

Clinical Trials on ortho-k lenses

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe