Skip to main content
OpenTrials
Completed

NCT Number: NCT00962208

Retardation of Myopia in Orthokeratology

The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry, The Hong Kong Polytechnic University

Hong Kong, China

About this study

Prevalence of myopia is high in Asian countries like Hong Kong. Orthokeratology has shown potential in slowing myopic progression but the efficacy is yet to be confirmed by a randomized clinical trial (RCT). The current RCT aims at studying the efficacy of orthokeratology in retardation of myopic progression by comparing the eye growth in terms of axial length elongation in children wearing orthokeratology lenses (study group) and those wearing single-vision spectacles (control group).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myopia (refractive sphere): > 0.50D and ≤ 4.00D
  • Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
  • Spherical equivalent (SE): > 0.75D and ≤ 4.50D
  • 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
  • Willingness to wear contact lenses or spectacles on a daily basis
  • 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
  • Prior experience with the use of rigid lenses (including orthokeratology)
  • Prior experience with myopia control treatment (e.g. refractive therapy or progressive add spectacles)
  • 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)

Treatment and study plan

orthokeratology lenses

Device

Nightly use of orthokeratology to correct the refractive error for a period of two years

Other names: Corneal reshaping therapy, Menicon Z Night Lens

single-vision spectacle lenses

Device

Daily use of spectacles to correct the refractive error for a period of two years

Other names: CR-39 lenses

Primary outcomes

  1. Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study

    Time frame: 2 years

    Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.

Secondary outcomes

  1. 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. Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Menicon Co., Ltd.

Registry information

Official study title

Orthokeratology for Myopic Control in Chinese Children - a Randomized Clinical Trial

Acronym: ROMIO

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 19, 2009
Registry last updated
Oct 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.