Peripheral Optics in Myopia and Orthokeratology

Myopia Clinical Trial

Official title:

Peripheral Refraction and Aberration in Myopic Progression and Myopic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978679
• Other study ID #: G-RGVM
• Status: Completed
• Phase: N/A
• First received: September 16, 2009
• Last updated: February 22, 2016
• Start date: March 2008
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• 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 objective of the current study is to investigate changes in peripheral refraction and aberration in children wearing orthokeratology lenses and single-vision spectacles.

Description:

Apart from being effective in reducing low to moderate myopia, orthokeratology has been shown to have potential in retarding myopic progression. The central cornea is flattened and peripheral optics altered in orthokeratology and it has been suggested that orthokeratology slows myopic progression through the alteration of peripheral optics. The aim of the current study is to investigate the changes in peripheral refraction and aberration in children wearing orthokeratology (study group) and single-vision spectacles (control group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 9 Years

Eligibility

Inclusion Criteria:

• Myopia (refractive sphere): > 0.50D and = 6.00D

• Astigmatism: with-the-rule astigmatism (axes 180 +/- 30) = 1.50D; astigmatism of other axes = 0.50D

• Spherical equivalent (SE): > 0.50D and = 6.75D (myopia)

• Best corrected monocular visual acuity: equal to or better than 6/7.5 in Snellen scale

• 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 myopic control treatment (e.g. refractive therapy or progressive 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: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Orthokeratology lenses
Nightly use of orthokeratology lenses to correct the refractive errors
• Spectacles
Daily use of single vision lenses to correct refractive errors

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 (4)

Charman WN, Mountford J, Atchison DA, Markwell EL. Peripheral refraction in orthokeratology patients. Optom Vis Sci. 2006 Sep;83(9):641-8. — View 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. — View Citation

Mathur A, Atchison DA. Effect of orthokeratology on peripheral aberrations of the eye. Optom Vis Sci. 2009 May;86(5):E476-84. doi: 10.1097/OPX.0b013e31819fa5aa. — 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	Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length		2 years	No