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Retardation of Myopia in Orthokeratology (ROMIO)

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
orthokeratology lenses
single-vision spectacle lenses
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring children, corneal reshaping, myopia, myopia control, orthokeratology

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • School of Optometry, The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

orthokeratology lenses

single-vision spectacle lenses

Arm Description

Children wearing orthokeratology at night for correcting of refractive error will be study group

Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group

Outcomes

Primary Outcome Measures

Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study
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 Outcome Measures

Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups
Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear

Full Information

First Posted
August 18, 2009
Last Updated
September 21, 2013
Sponsor
The Hong Kong Polytechnic University
Collaborators
Menicon Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00962208
Brief Title
Retardation of Myopia in Orthokeratology
Acronym
ROMIO
Official Title
Orthokeratology for Myopic Control in Chinese Children - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Menicon Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
children, corneal reshaping, myopia, myopia control, orthokeratology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
orthokeratology lenses
Arm Type
Experimental
Arm Description
Children wearing orthokeratology at night for correcting of refractive error will be study group
Arm Title
single-vision spectacle lenses
Arm Type
Other
Arm Description
Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group
Intervention Type
Device
Intervention Name(s)
orthokeratology lenses
Other Intervention Name(s)
Corneal reshaping therapy, Menicon Z Night Lens
Intervention Description
Nightly use of orthokeratology to correct the refractive error for a period of two years
Intervention Type
Device
Intervention Name(s)
single-vision spectacle lenses
Other Intervention Name(s)
CR-39 lenses
Intervention Description
Daily use of spectacles to correct the refractive error for a period of two years
Primary Outcome Measure Information:
Title
Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
Title
Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Cho, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry, The Hong Kong Polytechnic University
City
Hong Kong
State/Province
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15875367
Citation
Cho P, Cheung SW, Edwards M. The longitudinal orthokeratology research in children (LORIC) in Hong Kong: a pilot study on refractive changes and myopic control. Curr Eye Res. 2005 Jan;30(1):71-80. doi: 10.1080/02713680590907256.
Results Reference
background
PubMed Identifier
19416935
Citation
Walline JJ, Jones LA, Sinnott LT. Corneal reshaping and myopia progression. Br J Ophthalmol. 2009 Sep;93(9):1181-5. doi: 10.1136/bjo.2008.151365. Epub 2009 May 4.
Results Reference
background
PubMed Identifier
22969068
Citation
Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012 Oct 11;53(11):7077-85. doi: 10.1167/iovs.12-10565.
Results Reference
result
PubMed Identifier
23361504
Citation
Cheung SW, Cho P. Validity of axial length measurements for monitoring myopic progression in orthokeratology. Invest Ophthalmol Vis Sci. 2013 Mar 5;54(3):1613-5. doi: 10.1167/iovs.12-10434.
Results Reference
derived
PubMed Identifier
22390958
Citation
Chan KY, Cheung SW, Cho P. Clinical performance of an orthokeratology lens fitted with the aid of a computer software in Chinese children. Cont Lens Anterior Eye. 2012 Aug;35(4):180-4. doi: 10.1016/j.clae.2012.01.004. Epub 2012 Mar 3.
Results Reference
derived

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Retardation of Myopia in Orthokeratology

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