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Peripheral Optics in Myopia and Orthokeratology

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Orthokeratology lenses
Spectacles
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Children, Peripheral refraction, Aberration, Eyeball length, Myopic control, Myopia, Corneal reshaping, Orthokeratology

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • School of Optometry, The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Orthokeratology

Others

Arm Description

Myopic children wearing orthokeratology at night will be the study group

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2009
Last Updated
February 22, 2016
Sponsor
The Hong Kong Polytechnic University
Collaborators
Menicon Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00978679
Brief Title
Peripheral Optics in Myopia and Orthokeratology
Official Title
Peripheral Refraction and Aberration in Myopic Progression and Myopic Control
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Menicon Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Children, Peripheral refraction, Aberration, Eyeball length, Myopic control, Myopia, Corneal reshaping, Orthokeratology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orthokeratology
Arm Type
Experimental
Arm Description
Myopic children wearing orthokeratology at night will be the study group
Arm Title
Others
Arm Type
Other
Arm Description
Myopic children wearing single-vision spectacles in the daytime will serve as control group
Intervention Type
Device
Intervention Name(s)
Orthokeratology lenses
Other Intervention Name(s)
Menicon Z Night Lens 2, Menicon Z Night Lens 2 Toric
Intervention Description
Nightly use of orthokeratology lenses to correct the refractive errors
Intervention Type
Device
Intervention Name(s)
Spectacles
Other Intervention Name(s)
Glasses, Eyeglasses
Intervention Description
Daily use of single vision lenses to correct refractive errors
Primary Outcome Measure Information:
Title
Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Cho, PhD
Organizational Affiliation
School of Optometry, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry, The Hong Kong Polytechnic University
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
000000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19342979
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.
Results Reference
background
PubMed Identifier
15875367
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. doi: 10.1080/02713680590907256.
Results Reference
result
PubMed Identifier
19416935
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.
Results Reference
result
PubMed Identifier
16971842
Citation
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.
Results Reference
result

Learn more about this trial

Peripheral Optics in Myopia and Orthokeratology

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