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

Not Applicable

Recruiting

• Conditions: Myopic Progression

• Registration Number: NCT05192824
• Lead Sponsor: Tianjin Eye Hospital

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2021-11-19
• Status Verified: 2021-12
• Study Start: 2021-12-10
• Study First Submitted QC: 2021-12-30
• Last Update Submitted: 2021-12-30
• Study First Posted: 2022-01-14
• Last Update Posted: 2022-01-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in visual questionnaire as compared to baseline（Postoperative 6 months, 12 months, 18 months and 24 months）	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)	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）	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）	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）	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）	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）	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）	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）	baseline, postoperative 6 months, 12 months, 18 months and 24 months	The corneal surface asymmetry index (SAI) was measured by Corneal Topography.

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, Tianjin, China