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Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children

S

Shanghai Eye Disease Prevention and Treatment Center

Status

Unknown

Conditions

Myopia

Study type

Observational

Funder types

Other

Identifiers

NCT03516357
YFZX2017002

Details and patient eligibility

About

Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children

Full description

1.The primary objective of the current study is to investigate changes in uncorrected visual acuity, diopter, accommodation, peripheral refraction, IOP, tear film quality, corneal thickness, corneal topography, corneal biomechanical parameters, objective optical quality, corneal and conjunctiva sensitivity and choroidal thickness for children with different diopters after wearing orthokeratology lenses; 2. Through measure long-term changes of these parameters, including corneal topography, axial length, peripheral refraction, objective optical quality and choroidal thickness, to explore occurrence and development regularity of myopia.

Enrollment

300 estimated patients

Sex

All

Ages

8 to 15 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

    1. subjects were 6-16 years of age; 2.had no other ocular diseases aside from refractive error and no keratoconus (confirmed by pre-treatment corneal topography); 3. had an intraocular pressure (IOP) of <21 mmHg; 4. had an with-the- rule astigmatism (axes 180 ± 30) ≤ 1.50 D; 5.had a best corrected visual acuity(BCVA) ≤0.00 log MAR units in both eyes (Snellen equivalent to 20/20);

Exclusion criteria

    1. had binocular vision problems; 2.use medications that might affect refractive development; 3.had history of ortho-k or contact lens wear; 4. Ocular surface diseases and other eye diseases which can cause abnormalities of ocular surface; 5. Patients with histories of ocular injury or surgery; 6. Corneal staining and decentration of lens after wearing Ortho-k.

Trial design

300 participants in 3 patient groups

low myopia
Description:
-3.00D \< spherical equivalent refractive error \< -0.50D
moderate myopia
Description:
-6.00D \< spherical equivalent refractive error ≤ -3.0D
high myopia
Description:
spherical equivalent refractive error ≤ -6.0D

Trial contacts and locations

1

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Central trial contact

Zhu Mengjun, MD

Data sourced from clinicaltrials.gov

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