Myopic Progression
Conditions
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.
Interventions
DEVICEOrthokeratology lens
The intervention was according to the design of different optical zone and peripheral reverse curve
Sponsors
Tianjin Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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 |
Countries
China
Contacts
Primary ContactShuxian Zhang, MD
Outcome results
None listed