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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Completed
CT.gov ID
NCT02643342
Collaborator
Menicon Co., Ltd. (Industry), Queensland University of Technology (Other), Aston University (Other)
99
Enrollment
1
Location
3
Arms
37.5
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Orthokeratology
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
99 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye
Actual Study Start Date :
Jun 18, 2016
Actual Primary Completion Date :
Aug 3, 2019
Actual Study Completion Date :
Aug 3, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Single-vision glasses

Subjects wearing single-vision glasses CR-39 of refractive index 1.56.
Sham Comparator: Orthokeratology with normal compression factor

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

Device: Orthokeratology
Other Names:
  • ortho-k

    		•
    Active Comparator: Orthokeratology with increased compression factor

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

    Device: Orthokeratology
    Other Names:
  • ortho-k

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Axial length [every 6 monthly in 2 years]

      axial progression of the eyeball

    Secondary Outcome Measures

    1. Ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer [every 6 monthly in 2 years]

      ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer

    2. Corneal biomechanics (corneal response using ocular response) [every 6 monthly in 2 years]

      corneal response using ocular response

    3. Accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer [every 6 monthly in 2 years]

      accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer using different accommodation targets

    4. Choroidal thickness captured by Optical Coherent Tomographer (OCT) [every 6 monthly in 2 years]

      choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 School of Optometry, The Hong KOng Polytechnic University Hong Kong China

    Sponsors and Collaborators

    • The Hong Kong Polytechnic University
    • Menicon Co., Ltd.
    • Queensland University of Technology
    • Aston University

    Investigators

    • Principal Investigator: Pauline Cho, PhD, The Hong Kong Polytechnic University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Pauline Cho, Professor, The Hong Kong Polytechnic University
    ClinicalTrials.gov Identifier:
    NCT02643342
    Other Study ID Numbers:
    • HSEARS20150909002
    First Posted:
    Dec 31, 2015
    Last Update Posted:
    Jul 30, 2020
    Last Verified:
    Feb 1, 2020
    Keywords provided by Pauline Cho, Professor, The Hong Kong Polytechnic University
    myopia control
    orthokeratology
    Additional relevant MeSH terms:
    Disease Progression

    Study Results

    No Results Posted as of Jul 30, 2020