Retardation of Myopia in Orthokeratology

Myopia Clinical Trial

— ROMIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962208
• Other study ID #: H-ZG13
• Status: Completed
• Phase: N/A
• First received: August 18, 2009
• Last updated: September 21, 2013
• Start date: March 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2013
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• orthokeratology lenses
Nightly use of orthokeratology to correct the refractive error for a period of two years
• single-vision spectacle lenses
Daily use of spectacles to correct the refractive error for a period of two years

Locations

Country	Name	City	State
China	School of Optometry, The Hong Kong Polytechnic University	Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Menicon Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	No
Secondary	Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups		2 years	Yes
Secondary	Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear		2 years	No