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A Unified Index to Predict the Success Probability of Myopia Control

Primary Purpose

Myopia, Progressive

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
orthokeratology lens
multifocal soft contact lens
Single vision spectacles
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Progressive

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Older than 7 years of age or younger than 12 years of age, Spherical equivalent (SE) greater -1.00 D and less than-5.00 D, Corneal astigmatism ≤ 1.50 D, best-corrected visual acuity better than 20/25, No binocular vision dysfunction, No obvious angle kappa, No history of an OK-lens or MFCL wear or any other myopia control treatments such as atropine, application of atropine for cycloplegia during the past 30 days, No contact lens contraindications, No related ocular or systemic disease. Exclusion Criteria: Younger than 7 years of age or older than 12 years of age, Spherical equivalent (SE) less than -1.00 D or greater than-5.00 D, Corneal astigmatism > 1.50 D, Best-corrected visual acuity less than 20/25, Binocular vision dysfunction, Obvious angle kappa, History of an OK-lens or MFCL wear or any other myopia control treatments such as atropine, application of atropine for cycloplegia during the past 30 days, Contact lens contraindications, Related ocular or systemic disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    orthokeratology lens

    multifocal soft contact lens

    single vision spectacle

    Arm Description

    The subjects will wear an orthokeratology lens with 3-zone reverse geometry design. The subjects are instructed to wear the lenses for at least eight hours every night and are removed during daytime hours.

    The subjects will wear a multifocal soft contact lens during daytime hours and remove the lens at night

    The subjects will wear single vision spectacle lens as control.

    Outcomes

    Primary Outcome Measures

    axial length elongation
    The changes in axial length at the end of 12-month treatment will be computed.

    Secondary Outcome Measures

    pupillary myopia defocus dosage
    The myopia defocus dosage accumulated within the pupillary area

    Full Information

    First Posted
    March 6, 2023
    Last Updated
    September 8, 2023
    Sponsor
    Nova Southeastern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05773118
    Brief Title
    A Unified Index to Predict the Success Probability of Myopia Control
    Official Title
    A Unified Index to Predict the Success Probability of Myopia Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Recent personnel changes in the research team make it unrealistic to conduct this research project.
    Study Start Date
    January 2025 (Anticipated)
    Primary Completion Date
    January 2030 (Anticipated)
    Study Completion Date
    January 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nova Southeastern University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Orthokeratology lenses (OK-lens) and multifocal contact lenses (MFCL) are optical devices designed to slow down the progression of myopia. Both treatments a long-term commitment from doctors and patients. This study aims to develop a unified index to predict the success probability of myopia control at the early stage of treatment.
    Detailed Description
    An Orthokeratology lens (OK-lens) is a rigid contact lens with a reverse geometry on its back surface. Overnight OK-lens wearing flattens the central cornea (creating minus power) and steepens the mid-peripheral cornea (creating plus power). During the day, this inverted pattern of peripheral corneal refraction induces relative peripheral myopic defocus on the retina to slow down the axial growth. The central portion of an MFCL is designed with minus powers to correct for distance vision, and plus power is directly added to the peripheral part of the lens. Daytime MFCL wear imposes peripheral retinal myopic defocus when the lenses are worn. An MFCL can also reduce axial growth by 52% compared to a single vision spectacle or contact lens. Myopia control with OK-lens or MFCL requires a long-term commitment from doctors and patients to see the effect become apparent. It is paramount to estimate the probability that a patient would achieve effective control in myopic progression ideally before treatment begins or early during the course of treatment. To this end, efforts have been made to investigate the correlations between axial growth and possible contributing factors. Early research works have covered a variety of parameters at the baseline, including age, spherical equivalent (SE), corneal eccentricity, and corneal thickness. These measurements are nonspecific, indirect, and based on the assumption that their relationships to axial growth are linear, which often leads to contradictory findings and results that are hard to interpret by physicians. Therefore, in this study, we proposed a new index that takes pupil size into consideration by determining the summed relative myopic defocus dosage within the pupillary area (PMDD) to predict myopia control's success rate. This index will be determined for each eye, will be quantified one month after the lens dispensing, and will be used as the predictive variable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Progressive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    orthokeratology lens
    Arm Type
    Experimental
    Arm Description
    The subjects will wear an orthokeratology lens with 3-zone reverse geometry design. The subjects are instructed to wear the lenses for at least eight hours every night and are removed during daytime hours.
    Arm Title
    multifocal soft contact lens
    Arm Type
    Experimental
    Arm Description
    The subjects will wear a multifocal soft contact lens during daytime hours and remove the lens at night
    Arm Title
    single vision spectacle
    Arm Type
    Active Comparator
    Arm Description
    The subjects will wear single vision spectacle lens as control.
    Intervention Type
    Device
    Intervention Name(s)
    orthokeratology lens
    Intervention Description
    Subjects will wear orthokeratology lens at night. Axial length elongation over a period of 12-month will be recorded.
    Intervention Type
    Device
    Intervention Name(s)
    multifocal soft contact lens
    Intervention Description
    Subjects will wear multifocal soft contact lens during the day time. Axial length elongation over a period of 12-month will be recorded.
    Intervention Type
    Device
    Intervention Name(s)
    Single vision spectacles
    Intervention Description
    Subjects will wear single vision spectacles during the day. Axial length elongation over a period of 12-month will be recorded.
    Primary Outcome Measure Information:
    Title
    axial length elongation
    Description
    The changes in axial length at the end of 12-month treatment will be computed.
    Time Frame
    over 12 months
    Secondary Outcome Measure Information:
    Title
    pupillary myopia defocus dosage
    Description
    The myopia defocus dosage accumulated within the pupillary area
    Time Frame
    over 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Older than 7 years of age or younger than 12 years of age, Spherical equivalent (SE) greater -1.00 D and less than-5.00 D, Corneal astigmatism ≤ 1.50 D, best-corrected visual acuity better than 20/25, No binocular vision dysfunction, No obvious angle kappa, No history of an OK-lens or MFCL wear or any other myopia control treatments such as atropine, application of atropine for cycloplegia during the past 30 days, No contact lens contraindications, No related ocular or systemic disease. Exclusion Criteria: Younger than 7 years of age or older than 12 years of age, Spherical equivalent (SE) less than -1.00 D or greater than-5.00 D, Corneal astigmatism > 1.50 D, Best-corrected visual acuity less than 20/25, Binocular vision dysfunction, Obvious angle kappa, History of an OK-lens or MFCL wear or any other myopia control treatments such as atropine, application of atropine for cycloplegia during the past 30 days, Contact lens contraindications, Related ocular or systemic disease.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34096430
    Citation
    Wang D, Wen D, Zhang B, Lin W, Liu G, Du B, Lin F, Li X, Wei R. The Association between Fourier Parameters and Clinical Parameters in Myopic Children Undergoing Orthokeratology. Curr Eye Res. 2021 Nov;46(11):1637-1645. doi: 10.1080/02713683.2021.1917619. Epub 2021 Jun 6.
    Results Reference
    background
    PubMed Identifier
    31526284
    Citation
    Xia R, Su B, Bi H, Tang J, Lin Z, Zhang B, Jiang J. Good Visual Performance Despite Reduced Optical Quality during the First Month of Orthokeratology Lens Wear. Curr Eye Res. 2020 Apr;45(4):440-449. doi: 10.1080/02713683.2019.1668950. Epub 2019 Sep 24.
    Results Reference
    background
    PubMed Identifier
    32945207
    Citation
    Yang X, Bi H, Li L, Li S, Chen S, Zhang B, Wang Y. The Effect of Relative Corneal Refractive Power Shift Distribution on Axial Length Growth in Myopic Children Undergoing Orthokeratology Treatment. Curr Eye Res. 2021 May;46(5):657-665. doi: 10.1080/02713683.2020.1820528. Epub 2020 Sep 18.
    Results Reference
    background
    PubMed Identifier
    34720848
    Citation
    Liu G, Wu Y, Bi H, Wang B, Gu T, Du B, Tong J, Zhang B, Wei R. Time Course of Perceived Visual Distortion and Axial Length Growth in Myopic Children Undergoing Orthokeratology. Front Neurosci. 2021 Oct 13;15:693217. doi: 10.3389/fnins.2021.693217. eCollection 2021.
    Results Reference
    background
    PubMed Identifier
    35436922
    Citation
    Lin W, Gu T, Bi H, Du B, Zhang B, Wei R. The treatment zone decentration and corneal refractive profile changes in children undergoing orthokeratology treatment. BMC Ophthalmol. 2022 Apr 18;22(1):177. doi: 10.1186/s12886-022-02396-w.
    Results Reference
    background
    PubMed Identifier
    34177459
    Citation
    Jiang F, Huang X, Xia H, Wang B, Lu F, Zhang B, Jiang J. The Spatial Distribution of Relative Corneal Refractive Power Shift and Axial Growth in Myopic Children: Orthokeratology Versus Multifocal Contact Lens. Front Neurosci. 2021 Jun 9;15:686932. doi: 10.3389/fnins.2021.686932. eCollection 2021.
    Results Reference
    background
    PubMed Identifier
    30198800
    Citation
    Liu G, Jin N, Bi H, Du B, Gu T, Zhang B, Wei R. Long-Term Changes in Straylight Induced by Overnight Orthokeratology: An Objective Measure Using the Double-Pass System. Curr Eye Res. 2019 Jan;44(1):11-18. doi: 10.1080/02713683.2018.1514056. Epub 2018 Sep 10.
    Results Reference
    background

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    A Unified Index to Predict the Success Probability of Myopia Control

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