Retardation of Myopia in Orthokeratology

NCT00962208 | Completed Results

• 1 other identifier: H-ZG13
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

children; corneal reshaping; myopia; myopia control; orthokeratology

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups

  2 years

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

  2 years

Study Arms (2)

orthokeratology lenses

EXPERIMENTAL

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

Device: orthokeratology lenses

single-vision spectacle lenses

OTHER

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

Device: single-vision spectacle lenses

Interventions

orthokeratology lenses DEVICE

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

Also known as: Corneal reshaping therapy, Menicon Z Night Lens

orthokeratology lenses

single-vision spectacle lenses DEVICE

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

Also known as: CR-39 lenses

single-vision spectacle lenses

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Menicon Co., Ltd.: collaborator

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Hong Kong, Hong Kong, China

Location

Related Publications (6)

• 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.

  PMID: 15875367 BACKGROUND

• 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.

  PMID: 19416935 BACKGROUND

• 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.

  PMID: 22969068 RESULT

• Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

  PMID: 36809645 DERIVED

• 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.

  PMID: 23361504 DERIVED

• 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.

  PMID: 22390958 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Prof Pauline Cho
• Organization: The Hong Kong Polytechnic University

sopaulin@polyu.edu.hk

(852) 2766-6100

Study Officials

• Pauline Cho, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 19, 2009
• Study Start: March 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 28, 2013
• Results First Posted: September 20, 2013

Record last verified: 2013-07

Locations

CN (1)