Myopic Control for High Myopes Using Orthokeratology (HM-PRO)

July 11, 2013 updated by: Pauline Cho, The Hong Kong Polytechnic University

High Myopia - Partial Reduction Orthokeratology Study

The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic progression in low myopes. To date, clinical experience has shown the technique to be less effective in achieving full myopic reduction in high myopes. Would myopic control be possible for high myopes undergoing partial correction ortho-k treatment?

A randomized, longitudinal study is designed to investigate the efficacy of partial correction ortho-k in retardation of myopic progression in high myopic children. Eye growth in terms of axial length elongation in children wearing ortho-k and over-spectacles (to correct residual refractive errors) (study group) and those wearing single-vision spectacles (control group) will be evaluated and compared.

Study Type

Interventional

Enrollment (Actual)

52

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 SAR, 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

8 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Myopia (refractive sphere): > 5.75D
  • Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
  • Spherical equivalent (SE): > 5.75D
  • 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 for randomization
  • Availability for follow-up for at least 2 years

Exclusion Criteria:

  • Strabismus at distance or near
  • Contraindication for contact lens wear and orthokeratology (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: Orthokeratology lenses
Children wearing orthokeratology at night for partial correction and spectacles at daytime for residual refractive error will be study group
Device: Orthokeratology lenses
Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years
Other Names:
  • Corneal reshaping therapy
Other: Single-vision spectacle lenses
Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group
Device: Single-vision spectacle lenses
Daily use of spectacles to correct the refractive error for a period of two years
Other Names:
  • Glasses
  • Spectacles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the change in cycloplegic axial length in the study and control groups
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the incidence of adverse effects in cornea, the palpebral, bulbar and tarsal conjunctiva in the study and the control groups
Time Frame: 2 years
2 years
Rate of regression during the daytime
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

Collaborators

Procornea Nederland B.V.

Investigators

  • Principal Investigator: Pauline Cho, The Hong Kong Polytechnic University

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

Helpful Links

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, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 14, 2009

First Posted (Estimate)

September 15, 2009

Study Record Updates

Last Update Posted (Estimate)

July 12, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-RP3M

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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