A Unified Index to Predict the Success Probability of Myopia Control

NCT05773118 | Withdrawn DMC FDA Device

• 1 other identifier: 2022-597
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (1)

• axial length elongation

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

  over 12 months

Secondary Outcomes (1)

• pupillary myopia defocus dosage

  over 12 months

Study Arms (3)

orthokeratology lens

EXPERIMENTAL

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.

Device: orthokeratology lens

multifocal soft contact lens

EXPERIMENTAL

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

Device: multifocal soft contact lens

single vision spectacle

ACTIVE COMPARATOR

The subjects will wear single vision spectacle lens as control.

Device: Single vision spectacles

Interventions

orthokeratology lens DEVICE

Subjects will wear orthokeratology lens at night. Axial length elongation over a period of 12-month will be recorded.

orthokeratology lens

multifocal soft contact lens DEVICE

Subjects will wear multifocal soft contact lens during the day time. Axial length elongation over a period of 12-month will be recorded.

multifocal soft contact lens

Single vision spectacles DEVICE

Subjects will wear single vision spectacles during the day. Axial length elongation over a period of 12-month will be recorded.

single vision spectacle

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Southeastern University: lead

Related Publications (7)

• 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.

  PMID: 34096430 BACKGROUND

• 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.

  PMID: 31526284 BACKGROUND

• 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.

  PMID: 32945207 BACKGROUND

• 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.

  PMID: 34720848 BACKGROUND

• 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.

  PMID: 35436922 BACKGROUND

• 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.

  PMID: 34177459 BACKGROUND

• 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.

  PMID: 30198800 BACKGROUND

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share