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OpenTrials
Completed

NCT Number: NCT05956704

The Different Design of Orthokeratology

In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Eye Hospital

Tianjin, 300020, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The age is greater than 8 years and less than 18 years
  • The myopia was within -4.00D (including -4.00D), and the astigmatism was within 1.50D (including 1.50D) in both eyes.
  • Be able to complete 12 months of follow-up
  • They were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians

Exclusion criteria

  • One eye met the inclusion criteria
  • Patients with systemic diseases causing immunocompromised or affecting orthokeratology
  • There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc
  • Abnormal cornea
  • Previous corneal surgery or corneal trauma history
  • Active keratitis (e.g., corneal infection)
  • Patients with best corrected distance visual acuity of less than 5.0
  • Patients with corneal flat curvature lower than 39.00D, or higher than 48.00D
  • Patients with refractive instability
  • Patients with overt strabismus
  • The corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses
  • Patients with dry eye are not suitable for orthokeratology
  • Patients with corneal endothelial cell density less than 2000 cells /mm2
  • Patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days

Treatment and study plan

Orthokeratology with aspheric wide inversion zone design in the optical zone

Device

An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone

Orthokeratology with traditional spherical design in the optical zone

Device

Subjects wore the orthokeratology with traditional spherical design in the optical zone

Primary outcomes

  1. Changes in axial length

    Time frame: The change of baseline and 1years

    Axial length was measured with a biometer

Sponsors and collaborators

Lead sponsor

Tianjin Eye Hospital

Other

Registry information

Official study title

The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2023
Registry last updated
Jul 21, 2023

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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