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

Tianjin Eye Hospital

Status: Enrolling

Conditions: Myopic Progression

Treatments: Device: Orthokeratology lens

Study type: Interventional

Funder types: Other

Identifiers

NCT05192824

TianjinEH-Orthokeratology lens

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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200 participants in 5 patient groups

Single-vision glasses

No Intervention group

Description:

Subjects wearing single-vision glasses CR-39

Orthokeratology lenses group 1

Experimental group

Description:

Subjects wearing orthokeratology lenses of 5mm optical zone.

Treatment:

Device: Orthokeratology lens

Orthokeratology lenses group 2

Experimental group

Description:

Subjects wearing orthokeratology lenses of 5.5mm optical zone.

Treatment:

Device: Orthokeratology lens

Orthokeratology lenses group 3

Experimental group

Description:

Subjects wearing orthokeratology lenses of 6mm optical zone.

Treatment:

Device: Orthokeratology lens

Orthokeratology lenses group 4

Experimental group

Description:

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

Treatment:

Device: Orthokeratology lens