Clinical trial NCT05192824: Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality
Official title: Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopic Progression
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in axial length in 2 years
timeFrame: Every 6 months for a period 2 years
measure: Changes in Cycloplegic subjective refraction in 2 years
timeFrame: Every 6 months for a period 2 years
Secondary outcomes:
measure: Change in visual questionnaire as compared to baseline（Postoperative 6 months, 12 months, 18 months and 24 months）
timeFrame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
measure: Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
timeFrame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
measure: Change in contrast sensitivity as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
timeFrame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
measure: Change in choroidal thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
timeFrame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
measure: 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）
timeFrame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
measure: Change in corneal biomechanics parameters (SSI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
timeFrame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
measure: Change in peripheral refraction as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
timeFrame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
measure: Change in corneal surface regularity index (SRI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
timeFrame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
measure: Change in corneal surface asymmetry index (SAI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
timeFrame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.