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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-vision glasses | No Intervention | Subjects wearing single-vision glasses CR-39 | |
| Orthokeratology lenses group 1 | Experimental | Subjects wearing orthokeratology lenses of 5mm optical zone. |
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| Orthokeratology lenses group 2 | Experimental | Subjects wearing orthokeratology lenses of 5.5mm optical zone. |
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| Orthokeratology lenses group 3 | Experimental | Subjects wearing orthokeratology lenses of 6mm optical zone. |
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| Orthokeratology lenses group 4 | Experimental | Subjects wearing orthokeratology lenses of 6mm optical zone and the increased height of peripheral reverse curve. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthokeratology lens | Device | The intervention was according to the design of different optical zone and peripheral reverse curve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in axial length in 2 years | The axial length was measured by AL-scan | Every 6 months for a period 2 years |
| Changes in Cycloplegic subjective refraction in 2 years | The cycloplegic subjective refraction was evaluated by optometrist | Every 6 months for a period 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual questionnaire as compared to 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. | baseline, postoperative 6 months, 12 months, 18 months and 24 months |
| Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuxian Zhang, MD | Contact | +8618630996574 | xindewo2006@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Eye Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27464993 | Background | 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. | |
| 26826749 | Background | 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. |
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|
Ocular aberration measured by Zeiss i. Profiler Plus aberrometer |
| baseline, postoperative 6 months, 12 months, 18 months and 24 months |
| Change in contrast sensitivity as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months) | Contrast sensitivity measured by Stereo optical 6500 | baseline, postoperative 6 months, 12 months, 18 months and 24 months |
| Change in choroidal thickness captured by Optical Coherent Tomographer (OCT) as compared to 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 | baseline, postoperative 6 months, 12 months, 18 months and 24 months |
| 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) | Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) customized software | baseline, postoperative 6 months, 12 months, 18 months and 24 months |
| Change in corneal biomechanics parameters (SSI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months) | Corneal response parameters(SSI) was evaluated by Corvis ST. | baseline, postoperative 6 months, 12 months, 18 months and 24 months |
| Change in peripheral refraction as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months) | Peripheral refraction measured by multispectral refraction topography | baseline, postoperative 6 months, 12 months, 18 months and 24 months |
| Change in corneal surface regularity index (SRI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months) | The corneal surface regularity index (SRI) was measured by Corneal Topography. | baseline, postoperative 6 months, 12 months, 18 months and 24 months |
| Change in corneal surface asymmetry index (SAI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months) | The corneal surface asymmetry index (SAI) was measured by Corneal Topography. | baseline, postoperative 6 months, 12 months, 18 months and 24 months |
| 30705043 | Background | 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. |
| 33477514 | Background | Paune J, Fonts S, Rodriguez L, Queiros A. The Role of Back Optic Zone Diameter in Myopia Control with Orthokeratology Lenses. J Clin Med. 2021 Jan 18;10(2):336. doi: 10.3390/jcm10020336. |
| 31776061 | Background | 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. |