NCT00977236

Brief Summary

The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

July 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

Enrollment Period

3.4 years

First QC Date

September 14, 2009

Last Update Submit

July 11, 2013

Conditions

Myopia

Keywords

childrencorneal reshapingmyopiamyopia controlorthokeratology

Outcome Measures

Primary Outcomes (1)

  • Determine the change in cycloplegic axial length in the study and control groups

    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

  • Rate of regression during the daytime

    2 years

Study Arms (2)

Orthokeratology lenses

EXPERIMENTAL

Children wearing orthokeratology at night for partial correction and spectacles at daytime for residual 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 lensesDEVICE

Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years

Also known as: Corneal reshaping therapy
Orthokeratology lenses
Single-vision spectacle lensesDEVICE

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

Also known as: Glasses, Spectacles
Single-vision spectacle lenses

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Myopia (refractive sphere): \> 5.75D
  • Astigmatism: \< ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
  • Spherical equivalent (SE): \> 5.75D
  • 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
  • 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
  • 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 SAR, China

Location

Related Publications (5)

  • 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

  • Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d.

    PMID: 23645372RESULT

  • Charm J, Cho P. High myopia-partial reduction orthokeratology (HM-PRO): study design. Cont Lens Anterior Eye. 2013 Aug;36(4):164-70. doi: 10.1016/j.clae.2013.02.012. Epub 2013 Mar 18.

    PMID: 23518209RESULT

  • 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: 36809645DERIVED

Related Links

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • Pauline Cho

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

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

September 14, 2009

First Posted

September 15, 2009

Study Start

July 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations

CN(1)