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The Different Design of Orthokeratology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05956704
Recruitment Status : Completed
First Posted : July 21, 2023
Last Update Posted : July 21, 2023
Sponsor:
Information provided by (Responsible Party):
Tianjin Eye Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myopia Device: Orthokeratology with aspheric wide inversion zone design in the optical zone Device: Orthokeratology with traditional spherical design in the optical zone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth
Actual Study Start Date : December 1, 2020
Actual Primary Completion Date : June 1, 2023
Actual Study Completion Date : June 1, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Group Device: Orthokeratology with aspheric wide inversion zone design in the optical zone
An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone
Active Comparator: Control group Device: Orthokeratology with traditional spherical design in the optical zone
Subjects wore the orthokeratology with traditional spherical design in the optical zone
No Intervention: Blank control group


Outcome Measures
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Primary Outcome Measures :
  1. Changes in axial length [ Time Frame: The change of baseline and 1years ]
    Axial length was measured with a biometer


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05956704


Locations
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China
Tianjin Eye Hospital
Tianjin, China, 300020
Sponsors and Collaborators
Tianjin Eye Hospital
More Information
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Responsible Party: Tianjin Eye Hospital
ClinicalTrials.gov Identifier: NCT05956704    
Other Study ID Numbers: KY2023031
First Posted: July 21, 2023    Key Record Dates
Last Update Posted: July 21, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases