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A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye

Primary Purpose

Myopic Progression

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

About this trial

This is an interventional treatment trial for Myopic Progression focused on measuring myopia control, orthokeratology

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 6 to 10 years old
  • Myopia: between 0.50 D and 4.00 D in both eyes
  • Astigmatism: <1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
  • Anisometropia: ≤ 1.50 D
  • Symmetrical corneal topography with corneal toricity <2.00 D in both eyes
  • Agree for randomization

Exclusion Criteria:

  • Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
  • Any type of strabismus or amblyopia
  • Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
  • Rigid contact lenses (including orthokeratology lenses) experience
  • Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
  • Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
  • Poor compliance for lens wear or follow-up

Sites / Locations

  • School of Optometry, The Hong KOng Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Sham Comparator

Active Comparator

Arm Label

Single-vision glasses

Orthokeratology with normal compression factor

Orthokeratology with increased compression factor

Arm Description

Subjects wearing single-vision glasses CR-39 of refractive index 1.56.

Subjects wearing orthokeratology lenses of normal compression factor about 0.50-0.75D.

Subjects wearing orthokeratology lenses of increased compression factor about 1.50-1.75D.

Outcomes

Primary Outcome Measures

Axial length
axial progression of the eyeball

Secondary Outcome Measures

Ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer
ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer
Corneal biomechanics (corneal response using ocular response)
corneal response using ocular response
Accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer
accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer using different accommodation targets
Choroidal thickness captured by Optical Coherent Tomographer (OCT)
choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software

Full Information

First Posted
December 28, 2015
Last Updated
July 29, 2020
Sponsor
The Hong Kong Polytechnic University
Collaborators
Menicon Co., Ltd., Queensland University of Technology, Aston University
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1. Study Identification

Unique Protocol Identification Number
NCT02643342
Brief Title
A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye
Official Title
A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 18, 2016 (Actual)
Primary Completion Date
August 3, 2019 (Actual)
Study Completion Date
August 3, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Progression
Keywords
myopia control, orthokeratology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-vision glasses
Arm Type
No Intervention
Arm Description
Subjects wearing single-vision glasses CR-39 of refractive index 1.56.
Arm Title
Orthokeratology with normal compression factor
Arm Type
Sham Comparator
Arm Description
Subjects wearing orthokeratology lenses of normal compression factor about 0.50-0.75D.
Arm Title
Orthokeratology with increased compression factor
Arm Type
Active Comparator
Arm Description
Subjects wearing orthokeratology lenses of increased compression factor about 1.50-1.75D.
Intervention Type
Device
Intervention Name(s)
Orthokeratology
Other Intervention Name(s)
ortho-k
Primary Outcome Measure Information:
Title
Axial length
Description
axial progression of the eyeball
Time Frame
every 6 monthly in 2 years
Secondary Outcome Measure Information:
Title
Ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer
Description
ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer
Time Frame
every 6 monthly in 2 years
Title
Corneal biomechanics (corneal response using ocular response)
Description
corneal response using ocular response
Time Frame
every 6 monthly in 2 years
Title
Accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer
Description
accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer using different accommodation targets
Time Frame
every 6 monthly in 2 years
Title
Choroidal thickness captured by Optical Coherent Tomographer (OCT)
Description
choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software
Time Frame
every 6 monthly in 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 6 to 10 years old Myopia: between 0.50 D and 4.00 D in both eyes Astigmatism: <1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes Anisometropia: ≤ 1.50 D Symmetrical corneal topography with corneal toricity <2.00 D in both eyes Agree for randomization Exclusion Criteria: Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex) Any type of strabismus or amblyopia Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period Rigid contact lenses (including orthokeratology lenses) experience Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome) Ocular conditions which might affect the refractive error (for example, cataract, ptosis) Poor compliance for lens wear or follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Cho, PhD
Organizational Affiliation
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
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22150587
Citation
Lam CS, Lam CH, Cheng SC, Chan LY. Prevalence of myopia among Hong Kong Chinese schoolchildren: changes over two decades. Ophthalmic Physiol Opt. 2012 Jan;32(1):17-24. doi: 10.1111/j.1475-1313.2011.00886.x.
Results Reference
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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
background
PubMed Identifier
22969068
Citation
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.
Results Reference
background
PubMed Identifier
24003088
Citation
Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527.
Results Reference
background
PubMed Identifier
18434845
Citation
Gonzalez-Meijome JM, Villa-Collar C, Queiros A, Jorge J, Parafita MA. Pilot study on the influence of corneal biomechanical properties over the short term in response to corneal refractive therapy for myopia. Cornea. 2008 May;27(4):421-6. doi: 10.1097/ICO.0b013e318164e49d.
Results Reference
background
PubMed Identifier
22495031
Citation
Wolffsohn JS, Safeen S, Shah S, Laiquzzaman M. Changes of corneal biomechanics with keratoconus. Cornea. 2012 Aug;31(8):849-54. doi: 10.1097/ICO.0b013e318243e42d.
Results Reference
background
PubMed Identifier
18055781
Citation
Tse DY, Lam CS, Guggenheim JA, Lam C, Li KK, Liu Q, To CH. Simultaneous defocus integration during refractive development. Invest Ophthalmol Vis Sci. 2007 Dec;48(12):5352-9. doi: 10.1167/iovs.07-0383.
Results Reference
background
PubMed Identifier
18426426
Citation
Chan B, Cho P, Mountford J. The validity of the Jessen formula in overnight orthokeratology: a retrospective study. Ophthalmic Physiol Opt. 2008 May;28(3):265-8. doi: 10.1111/j.1475-1313.2008.00545.x.
Results Reference
background
PubMed Identifier
32420450
Citation
Wan K, Lau JK, Cheung SW, Cho P. Orthokeratology with increased compression factor (OKIC): study design and preliminary results. BMJ Open Ophthalmol. 2020 May 4;5(1):e000345. doi: 10.1136/bmjophth-2019-000345. eCollection 2020.
Results Reference
derived

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A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye

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