NCT00978679

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

7.8 years

First QC Date

September 16, 2009

Last Update Submit

February 22, 2016

Conditions

Myopia

Keywords

ChildrenPeripheral refractionAberrationEyeball lengthMyopic controlMyopiaCorneal reshapingOrthokeratology

Outcome Measures

Primary Outcomes (1)

  • Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length

    2 years

Study Arms (2)

Orthokeratology

EXPERIMENTAL

Myopic children wearing orthokeratology at night will be the study group

Device: Orthokeratology lenses

Others

OTHER

Myopic children wearing single-vision spectacles in the daytime will serve as control group

Device: Spectacles

Interventions

Orthokeratology lensesDEVICE

Nightly use of orthokeratology lenses to correct the refractive errors

Also known as: Menicon Z Night Lens 2, Menicon Z Night Lens 2 Toric
Orthokeratology
SpectaclesDEVICE

Daily use of single vision lenses to correct refractive errors

Also known as: Glasses, Eyeglasses
Others

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Hong Kong, Hong Kong, 000000, China

Location

Related Publications (4)

  • 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.

    PMID: 19342979BACKGROUND

  • 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: 15875367RESULT

  • 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: 19416935RESULT

  • Charman WN, Mountford J, Atchison DA, Markwell EL. Peripheral refraction in orthokeratology patients. Optom Vis Sci. 2006 Sep;83(9):641-8. doi: 10.1097/01.opx.0000232840.66716.af.

    PMID: 16971842RESULT

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • Pauline Cho, PhD

    School of Optometry, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 17, 2009

Study Start

March 1, 2008

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

CN(1)