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Completed

NCT Number: NCT02643342

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

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.

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Key information

Conditions

Myopic Progression

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry, The Hong KOng Polytechnic University

Hong Kong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthokeratology

Device

Other names: ortho-k

Primary outcomes

  1. Axial length

    Time frame: every 6 monthly in 2 years

    axial progression of the eyeball

Secondary outcomes

  1. Ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer

    Time frame: every 6 monthly in 2 years

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

  2. Corneal biomechanics (corneal response using ocular response)

    Time frame: every 6 monthly in 2 years

    corneal response using ocular response

  3. Accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer

    Time frame: 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)

    Time frame: every 6 monthly in 2 years

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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Aston University
  • Menicon Co., Ltd.
  • Queensland University of Technology

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 31, 2015
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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