A Unified Index to Predict the Success Probability of Myopia Control

Myopia, Progressive Clinical Trial

Official title:

A Unified Index to Predict the Success Probability of Myopia Control

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05773118
• Other study ID #: 2022-597
• Status: Withdrawn
• Phase: N/A
• Start date: January 2025
• Est. completion date: January 2030

Study information

• Verified date: September 2023
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Device:
• orthokeratology lens
Subjects will wear orthokeratology lens at night. Axial length elongation over a period of 12-month will be recorded.
• multifocal soft contact lens
Subjects will wear multifocal soft contact lens during the day time. Axial length elongation over a period of 12-month will be recorded.
• Single vision spectacles
Subjects will wear single vision spectacles during the day. Axial length elongation over a period of 12-month will be recorded.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nova Southeastern University

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	axial length elongation	The changes in axial length at the end of 12-month treatment will be computed.	over 12 months
Secondary	pupillary myopia defocus dosage	The myopia defocus dosage accumulated within the pupillary area	over 12 months