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Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters

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:

  1. 6 to 10 years old
  2. Myopia: between 0.50 D and 4.00 D in both eyes
  3. 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
  4. Anisometropia: ≤ 1.50 D
  5. Symmetrical corneal topography with corneal toricity <2.00 D in both eyes
  6. Agree for randomization

Exclusion Criteria:

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

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Ortho-k lens with normal compression factor

Ortho-k lenses with increased compression factor

Arm Description

The eye wears ortho-k lens with normal compression factor to achieve plano (+/- 0.25D) correction.

The eye wears ortho-k lenses with increased compression factor to achieve 1 diopter (+/- 0.25D) over correction.

Outcomes

Primary Outcome Measures

Changes in Spherical Equivalent Refraction
Maximum plus for maximum visual acuity was used as the criterion for subjective refraction. Spherical equivalent refraction was calculated by adding the sum of the sphere power with half of the cylinder power.

Secondary Outcome Measures

Changes in Subfoveal Choroidal Thickness
The subfoveal choroidal thickness was determined as the thickness between the outer retinal pigment epithelium/Bruch's membrane complex and the inner chorioscleral interface.
Changes in Higher Order Aberrations
Ocular higher order aberrations were measured using Shack-Hartmann aberrometer. The wavefront data was fitted with a sixth order Zernike polynomial over a 5-mm pupil size.

Full Information

First Posted
December 28, 2015
Last Updated
August 30, 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
NCT02643875
Brief Title
Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters
Official Title
Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2016 (Actual)
Primary Completion Date
November 18, 2016 (Actual)
Study Completion Date
November 18, 2016 (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

5. Study Description

Brief Summary
Orthokeratology (ortho-k) is a clinical technique that uses reverse geometry rigid gas permeable contact lens exerting positive pressure on the central cornea to temporary reduce refractive error. Researchers have shown that this treatment is effective for myopia control in low to high myopes, with and without astigmatism. Most designs of ortho-k lenses in the market are fitted based on the Jessen formula. The compression factor was introduced to compensate for the regression of the ortho-k effect during the no lens-wear period, so that the wearer can obtain clear distance vision throughout the day and most lens designs use a compression factor of 0.50-0.75 D. However, in a retrospective study (mixed brands of ortho-k lenses), it showed that most patients did not achieve an over-correction of 0.75 D. In order to achieve an over-correction of 0.75 D, an extra flattening power of about 1.50 D instead of 0.75 D should be be targeted. The increased compression factor is expected to increase the target reduction and it may play a role in myopic control and providing a higher successful rate in fitting ortho-k lenses.
Detailed Description
Subjects were fitted with ortho-k lenses of conventional (0.75 D) and increased (1.75 D) compression factor. The laterality of the compression factor for each subject was randomised. Subjects were instructed and trained with proper lens handling and disinfection procedures. Lenses were given to the subjects only when they demonstrated proper techniques. All subjects were required to attend regular follow-ups (baseline, first overnight, and weekly over one-month period). The follow-ups were scheduled (except for the first overnight which was scheduled in the early morning) at a similar time to the baseline visit (+/- 2 hours) to minimise any potential influence of diurnal variation on ocular biometrics. Additional unscheduled visits were provided when necessary to ensure good ocular health and vision throughout the study period.

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
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ortho-k lens with normal compression factor
Arm Type
Sham Comparator
Arm Description
The eye wears ortho-k lens with normal compression factor to achieve plano (+/- 0.25D) correction.
Arm Title
Ortho-k lenses with increased compression factor
Arm Type
Active Comparator
Arm Description
The eye wears ortho-k lenses with increased compression factor to achieve 1 diopter (+/- 0.25D) over correction.
Intervention Type
Device
Intervention Name(s)
Orthokeratology
Intervention Description
It is a kind of rigid permeable lens.
Primary Outcome Measure Information:
Title
Changes in Spherical Equivalent Refraction
Description
Maximum plus for maximum visual acuity was used as the criterion for subjective refraction. Spherical equivalent refraction was calculated by adding the sum of the sphere power with half of the cylinder power.
Time Frame
baseline and one month
Secondary Outcome Measure Information:
Title
Changes in Subfoveal Choroidal Thickness
Description
The subfoveal choroidal thickness was determined as the thickness between the outer retinal pigment epithelium/Bruch's membrane complex and the inner chorioscleral interface.
Time Frame
baseline and one month
Title
Changes in Higher Order Aberrations
Description
Ocular higher order aberrations were measured using Shack-Hartmann aberrometer. The wavefront data was fitted with a sixth order Zernike polynomial over a 5-mm pupil size.
Time Frame
baseline and one month

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
The Hong Kong Polytechnic University
City
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
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
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
31704093
Citation
Wan K, Lau JK, Cheung SW, Cho P. Refractive and corneal responses of young myopic children to short-term orthokeratology treatment with different compression factors. Cont Lens Anterior Eye. 2020 Feb;43(1):65-72. doi: 10.1016/j.clae.2019.10.134. Epub 2019 Nov 6.
Results Reference
result
PubMed Identifier
31264269
Citation
Lau JK, Vincent SJ, Cheung SW, Cho P. The influence of orthokeratology compression factor on ocular higher-order aberrations. Clin Exp Optom. 2020 Jan;103(1):123-128. doi: 10.1111/cxo.12933. Epub 2019 Jul 1.
Results Reference
result
PubMed Identifier
31360614
Citation
Lau JK, Wan K, Cheung SW, Vincent SJ, Cho P. Weekly Changes in Axial Length and Choroidal Thickness in Children During and Following Orthokeratology Treatment With Different Compression Factors. Transl Vis Sci Technol. 2019 Jul 23;8(4):9. doi: 10.1167/tvst.8.4.9. eCollection 2019 Jul.
Results Reference
result

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Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters

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