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

Myopic Progression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192824
• Other study ID #: TianjinEH-Orthokeratology lens
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2021
• Source: Tianjin Eye Hospital
• Contact: Shuxian Zhang, MD
• Phone: +8618630996574
• Email: xindewo2006[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease Progression
• Myopia
• Myopic Progression

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in axial length in 2 years	The axial length was measured by AL-scan	Every 6 months for a period 2 years
Primary	Changes in Cycloplegic subjective refraction in 2 years	The cycloplegic subjective refraction was evaluated by optometrist	Every 6 months for a period 2 years
Secondary	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
Secondary	Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)	Ocular aberration measured by Zeiss i. Profiler Plus aberrometer	baseline, postoperative 6 months, 12 months, 18 months and 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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