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

NCT ID: NCT05192824

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-10
• Study Completion Date: 2025-12-31

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.

Conditions

Myopic Progression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single-vision glasses

Subjects wearing single-vision glasses CR-39

Group Type: NO_INTERVENTION

No interventions assigned to this group

Orthokeratology lenses group 1

Subjects wearing orthokeratology lenses of 5mm optical zone.

Group Type: EXPERIMENTAL

Orthokeratology lens

Intervention Type: DEVICE

The intervention was according to the design of different optical zone and peripheral reverse curve

Orthokeratology lenses group 2

Subjects wearing orthokeratology lenses of 5.5mm optical zone.

Group Type: EXPERIMENTAL

Orthokeratology lens

Intervention Type: DEVICE

The intervention was according to the design of different optical zone and peripheral reverse curve

Orthokeratology lenses group 3

Subjects wearing orthokeratology lenses of 6mm optical zone.

Group Type: EXPERIMENTAL

Orthokeratology lens

Intervention Type: DEVICE

The intervention was according to the design of different optical zone and peripheral reverse curve

Orthokeratology lenses group 4

Subjects wearing orthokeratology lenses of 6mm optical zone and the increased height of peripheral reverse curve.

Group Type: EXPERIMENTAL

Orthokeratology lens

Intervention Type: DEVICE

The intervention was according to the design of different optical zone and peripheral reverse curve

Interventions

Orthokeratology lens

The intervention was according to the design of different optical zone and peripheral reverse curve

Intervention Type: DEVICE

Other Intervention Names

Ortho-K

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shuxian zhang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuxian Zhang, MD

Role: CONTACT

xindewo2006@163.com

+8618630996574

Facility Contacts

Shuxian Zhang

Role: primary

xindewo2006@163.com

+8618630996574

References

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.

Reference Type: BACKGROUND

PMID: 27464993 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26826749 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30705043 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33477514 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31776061 (View on PubMed)

Other Identifiers

TianjinEH-Orthokeratology lens

Identifier Type: -

Identifier Source: org_study_id