Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality

Overview

This study was aimed to evaluate the effects of different Orthokeratology,including the size of central optical zone and the height of peripheral reverse curve, on myopia control and visual quality.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2025

Detailed Description

This study was aimed to evaluate the effects of different Orthokeratology on myopia control and visual quality. The different optical zone of Orthokeratology lens was divided into 4 groups, ranged from 5.5 mm to 6 mm. And the control group subjects with the single glasses was included. The effectiveness of Orthokeratology was measured by axial length progression. The visual quality of subjects was evaluated by a questionnaire, contrast sensitivity and wavefront aberration.

Interventions

  • Device: Orthokeratology lens
    • The intervention was according to the design of different optical zone and peripheral reverse curve

Arms, Groups and Cohorts

  • No Intervention: Single-vision glasses
    • Subjects wearing single-vision glasses CR-39
  • Experimental: Orthokeratology lenses group 1
    • Subjects wearing orthokeratology lenses of 5mm optical zone.
  • Experimental: Orthokeratology lenses group 2
    • Subjects wearing orthokeratology lenses of 5.5mm optical zone.
  • Experimental: Orthokeratology lenses group 3
    • Subjects wearing orthokeratology lenses of 6mm optical zone.
  • Experimental: Orthokeratology lenses group 4
    • Subjects wearing orthokeratology lenses of 6mm optical zone and the increased height of peripheral reverse curve.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in axial length in 2 years
    • Time Frame: Every 6 months for a period 2 years
    • The axial length was measured by AL-scan
  • Changes in Cycloplegic subjective refraction in 2 years
    • Time Frame: Every 6 months for a period 2 years
    • The cycloplegic subjective refraction was evaluated by optometrist

Secondary Measures

  • Change in visual questionnaire as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
    • Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
    • The symptoms score measured by a visual questionnaire, each symptom was evaluated on a scale of 0 to 10.
  • Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
    • Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
    • Ocular aberration measured by Zeiss i. Profiler Plus aberrometer
  • Change in contrast sensitivity as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
    • Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
    • Contrast sensitivity measured by Stereo optical 6500
  • Change in choroidal thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
    • Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
    • choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software
  • Change in Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
    • Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
    • Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) customized software
  • Change in corneal biomechanics parameters (SSI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months)
    • Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
    • Corneal response parameters(SSI) was evaluated by Corvis ST.
  • Change in peripheral refraction as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months)
    • Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
    • Peripheral refraction measured by multispectral refraction topography
  • Change in corneal surface regularity index (SRI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months)
    • Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
    • The corneal surface regularity index (SRI) was measured by Corneal Topography.
  • Change in corneal surface asymmetry index (SAI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months)
    • Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
    • The corneal surface asymmetry index (SAI) was measured by Corneal Topography.

Participating in This Clinical Trial

Inclusion Criteria

  • Myopia: between -1.00D and 4.00D in both eyes – Astigmatism: <1.5D for with-the-rule astigmatism, <1.00D for the against-the-rule astigmatism – Visual acuity: the best corrected vision acuity(BCVA)≥20/20 in both eyes – Subjects that volunteer to participate in the clinical trial and sign informed consent Exclusion Criteria:

  • Contraindications of wearing Ortho-K. – Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases. – Any type of strabismus or amblyopia – Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome) – Ocular conditions which might affect the refractive error (for example, cataract, ptosis)

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 13 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Tianjin Eye Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shuxian zhang, Director – Tianjin Eye Hospital
  • Overall Contact(s)
    • Shuxian Zhang, MD, +8618630996574, xindewo2006@163.com

References

He M, Du Y, Liu Q, Ren C, Liu J, Wang Q, Li L, Yu J. Effects of orthokeratology on the progression of low to moderate myopia in Chinese children. BMC Ophthalmol. 2016 Jul 27;16:126. doi: 10.1186/s12886-016-0302-5.

Huang J, Wen D, Wang Q, McAlinden C, Flitcroft I, Chen H, Saw SM, Chen H, Bao F, Zhao Y, Hu L, Li X, Gao R, Lu W, Du Y, Jinag Z, Yu A, Lian H, Jiang Q, Yu Y, Qu J. Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123(4):697-708. doi: 10.1016/j.ophtha.2015.11.010. Epub 2016 Jan 27.

Hu Y, Wen C, Li Z, Zhao W, Ding X, Yang X. Areal summed corneal power shift is an important determinant for axial length elongation in myopic children treated with overnight orthokeratology. Br J Ophthalmol. 2019 Nov;103(11):1571-1575. doi: 10.1136/bjophthalmol-2018-312933. Epub 2019 Jan 31.

Pauné J, Fonts S, Rodríguez L, Queirós A. The Role of Back Optic Zone Diameter in Myopia Control with Orthokeratology Lenses. J Clin Med. 2021 Jan 18;10(2). pii: 336. doi: 10.3390/jcm10020336.

Gifford P, Tran M, Priestley C, Maseedupally V, Kang P. Reducing treatment zone diameter in orthokeratology and its effect on peripheral ocular refraction. Cont Lens Anterior Eye. 2020 Feb;43(1):54-59. doi: 10.1016/j.clae.2019.11.006. Epub 2019 Nov 24.

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