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Completed

NCT Number: NCT02643875

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

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.

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Key information

Conditions

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong, China

About this study

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.

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

It is a kind of rigid permeable lens.

Primary outcomes

  1. Changes in Spherical Equivalent Refraction

    Time frame: baseline and one month

    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 outcomes

  1. Changes in Subfoveal Choroidal Thickness

    Time frame: baseline and one month

    The subfoveal choroidal thickness was determined as the thickness between the outer retinal pigment epithelium/Bruch's membrane complex and the inner chorioscleral interface.

  2. Changes in Higher Order Aberrations

    Time frame: baseline and one month

    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.

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
2016
Study completion
2016
First posted
Dec 31, 2015
Registry last updated
Sep 18, 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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